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Clinical Research in Southampton
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Current funding calls
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Auto Generated Title Here you can find new grant funding calls from various funders. Links on the right will take you directly to other calls with specific key funders. Keep up-to-date with COVID-19 funding calls and resources The Health Research Authority is publishing details about all approved COVID-19 research studies, within their dedicated COVID-19 section. More information New research priorities identified for aerosol generating procedures related to COVID-19 New funding opportunities are likely to result from the identification of a new set of research priorities relating to the COVID-19 pandemic. Details will be published here as they are made available. Five new research priorities have been identified through the NIHR expert review process, with the purpose of providing evidence to understand and assess aerosol generation and the infective risk associated with individual AGPs as well as broader questions about airborne transmission of COVID-19 in healthcare settings. Understanding the fundamental aerobiology Including virus distribution and viability in airborne particles. Risk factors for transmissibility Understanding and quantifying the risk of transmissibility across multiple domains (including patient, procedure, environment, pathogen and healthcare professional factors) in order to generate a clinically applicable risk model. Mitigating precautions and their components Identifying which mitigating precautions are important and how they work: to include clinical efficacy testing of PPE, environmental measures (e.g. ventilation, filtration), and other barrier devices. Transmission of COVID-19 and other pathogens Investigating the contribution of inhalation versus inoculation for infection risk from AGPs and other healthcare interventions. Understanding infective risk perception, behaviours and acceptability of mitigation strategies This will include diverse groups of healthcare workers, patients and the public. More information EPSRC - healthcare technologies investigator-led grant Funder: Engineering and Physical Sciences Research Council Closing date: n/a - OPEN CALL Healthcare technologies investigator-led research grants are for researchers at UK higher education institutions, research council institutes, UKRI-approved independent research organisations and NHS bodies. We strongly encourage collaboration with relevant healthcare professionals, other researchers, industry, the public sector and other relevant partners. We are looking for researchers in engineering, physical sciences, information and communications technologies (ICT) and mathematical sciences who want to apply their expertise to healthcare challenges. Projects can range in size from small short-term grants to multi-million-pound research programmes lasting several years. There is no limit on the size of the grant or length of the project. We will award 80% of the full economic costs of the project, and your organisation must agree to find the balance. More information UKRI - addressing limitations in manufacturing nucleic acid therapeutics Funder: UKRI Closing date: n/a - OPEN CALL Apply for funding to set up a research consortium addressing challenges in the manufacture of nucleic acid therapeutics. Current manufacture challenges include but are not limited to: scale of production product purity, stereochemistry and reproducibility sustainable production novel chemistries synthesis efficiency analytical oligonucleotide characterisation. The consortium can include academic and industrial organisations in the UK and abroad. The lead organisation must be UK-based. More information NIHR - NICE rolling call for research studies addressing NICE research recommendations Funder: NIHR Closing date: various, see below The NIHR research programmes (EME, HTA, PHR and HS&DR) are interested in receiving applications to meet recommendations in research identified in NICE guidance published from 2015 onwards (for the purposes of this call, NICE guidance includes the following: clinical, social care, public health, technology appraisals, interventional procedures and diagnostics). Proposals must be within the remit of one of the participating NIHR research programmes and the primary outcome measure must be health related. Proposals must be within the remit of at least one of the following participating NIHR Programmes. However, applications which span the remit of one or more programme are welcome. Health Technology Assessment (deadline 05 January 2022) Public Health Research (deadline: 30 November 2021) Sight Research UK - translational research award Funder: Sight Research UK Closing date: 30 November 2021 Sight Research UK funds pioneering research into the causes of eye disease, in order to develop better prevention methods and more effective treatments for children and adults. The Translational Research Award supports research projects with a clearly defined pathway to achieving patient benefit. Its goal is to help to accelerate the translation of scientific findings to the early stages of development of new therapies, devices, and diagnostics. Sight Research UK welcomes projects that have robust commercial potential, likely to attract large scale follow-on funding from other charitable, statutory or industry funders. Eligible projects must: Be based on unmet clinical need. Aim to generate lead candidates for therapeutic applications. Be relevant to and highly promising in the clinical setting (these are not early stage, proof of concept studies, instead they have already shown that the idea might be used as therapy in man). Be focused on assessing properties such as potency, efficacy, selectivity, or bioavailability of compounds identified by previous research as potentially strong candidates for therapeutic applications. Have a clear pathway to apply for funding such as the MRC Confidence in Concept, MRC Development Pathway Funding Scheme type funding and other similar funding schemes. More information NIHR Public Health Research Programme - researcher-led workstream Funder: NIHR Closing date: 30 November 2021 The Public Health Research (PHR) Programme funds research to generate evidence to inform the delivery of non-NHS interventions, intended to improve the health of the public, and reduce inequalities in health. The Public Health Research Programme are accepting stage 1 applications to their researcher-led workstream. More information NIHR Public Health Research Programme - dementia research call Funder: NIHR Closing date: 30 November 2021 This National Institute for Health Research (NIHR) call invites proposals for dementia research to address important health and social care questions. Research could involve any aspect of prevention, diagnosis, treatment, support or care, and related health and social care services. Applications which involve investigators spanning a range of specialties are encouraged and partnership with national charities welcomed. The HTA and EME programmes are also featuring this research area - see below 7 December and 5 January. More information British Geriatrics Society - specialist registrar research start-up grants Funder: BGS Closing date: 30 November 2021 The British Geriatrics Society Specialist Registrar Research Start-Up Grant scheme provides grants to individuals who want to get a research project started. The aim is to allow young doctors to follow through ideas at relatively short notice, to enable advantage to be taken of unique or rare opportunities, and to provide short-term assistance to speculative and innovative research that may be at an early stage. The grants may support a complete project or, where appropriate, support a pilot study to enable an application for external project grant support to be made. The grants are eligible for National Institute for Health Research (NIHR ) non-commercial partner status. More information NIHR Development and Skills Enhancement Award Round 8 Funder: NIHR Closing date: 30 November 2021 The Development and Skills Enhancement Award (DSE) provides a maximum of 1 year of funding for post-doctoral NIHR Academy Members to gain skills and experience for the next phase of their research career. As an applicant you will be required to demonstrate the new skills and experience you hope to gain through the award, and how it will benefit your future career in research. More Information NIHR PHR Programme 21/560 - James Lind Alliance priority setting partnerships rolling call Funder: NIHR Closing date: 30 November 2021 The Public Health Research (PHR) Programme funds research to generate evidence to inform the delivery of non-NHS interventions, intended to improve the health of the public, and reduce inequalities in health. The JLA Priority Setting Partnerships facilitate patients, carers and clinicians to work collaboratively to identify research priorities in particular areas of health and care. Their aim is to ensure that health research funders are aware of the issues that are important to the people who need to use the research in their daily lives. The NIHR PHR programme recognises the importance of the research priorities identified by the James Lind Alliance Priority Setting Partnerships and is interested in receiving high-quality applications which address them More information MRC - advancing adolescent mental health and wellbeing research Funder: Medical Research Council Closing date: 1 December 2021 Apply for funding to help improve research in the field of ‘ adolescence, mental health and the developing mind ’ through: methodological innovation capability building This opportunity will support projects that help researchers in delivering more relevant, valid, reproducible, mechanistically informed, multi-level and translationally scalable research in adolescent mental health over the next decade. Outputs from these projects may also allow new research questions to be investigated. Proposals should: address a clear area of unmet need with regard to existing research methods, concepts, tools or measures identify innovative new approaches for conducting mental health and wellbeing research with adolescents. More information NIHR - Health Technology Assessment Programme, commissioned workstreams Funder: NIHR Closing date: 1 December 2021 21/532 Intensive Interaction for children and young people with profound and multiple learning disabilities 21/534 Surgical management of successfully reduced incarcerated inguinal hernia in children 21/535 Follow-up strategy after radical treatment for prostate cancer 21/536 Sodium bicarbonate in neonatal care 21/537 Neuroendoscopic lavage for preterm babies with post-haemorrhagic ventricular dilatation 21/538 Benefits and harms of reduced dose oral isotretinoin in the management of acne vulgaris 21/539 Benefits and harms of maintenance therapy for refractory acne vulgaris or previous relapses by reduced dose isotretinoin regimens 21/540 Pharmacological treatments for low back pain or sciatica 21/542 Medication to manage sexual preoccupation in sex offenders 21/552 Microsuction compared with irrigation to remove earwax Diabetes UK - small grants and project grants Funder: Diabetes UK Closing date: 1 December 2021 Diabetes UK aims to improve lives through pioneering research into all forms of diabetes and diabetes-related complications. The work they support helps us understand the causes of diabetes, bring about life-changing breakthroughs in care, treatment and prevention and brings us closer to a cure. The following calls are open for application: Project grants : For high quality, hypothesis driven diabetes research projects, lasting up to five years and costing less than £ 500,000. Current research priority areas are: (1) New glucose monitoring technologies in inpatient care; (2) Understanding the pathogenesis of diabetes that develops atypically, or in minority populations Deadline for applications: 01 December 2021 Early-Career Small Grants : supports early-career basic scientists and members of Allied Health Professions to undertake small research projects related to diabetes. The scheme will enable scientists at an early stage in their career to develop their work and go on to obtain additional grant funding from other organisations. Nurses, pharmacists and members of the Allied Health Professions who meet the eligibility criteria may apply through this scheme. Deadline for applications: 01 December 2021 Diabetes UK & Great Foundations - addressing the issues in foot care which lead people with diabetes developing foot conditions Funder: Diabetes UK and Great Foundations Closing date: 1 December 2021 Diabetes UK and Great Foundations are inviting proposals addressing the issues which lead to people with diabetes developing ulcers or other diabetes-related foot conditions and these then progressing further. Preventing foot ulcers, amputations and other severe foot complications in people with diabetes is a key priority for the Diabetes Research Steering Group. There is a clear need for innovative approaches to do this, but these need to consider the findings of previous studies and address factors in foot care which may have previously not been subject to research. These include social factors which present significant barriers to care or treatment, the difficulty people with neuropathy have in detecting and adapting to foot conditions and the need for effective and rapid referrals for foot care when it is needed. More Information Versus Arthritis & MSK TRC - accelerating new treatments Funder: NIHR/Versus Arthritis Closing date: 1 December 2021 As part of the UK Musculoskeletal Translational Research Collaboration (MSK TRC) we are launching the second call for research projects focused on mechanistic experimental/translational medicine studies in humans across the areas of prevention, diagnosis or treatment that are aimed at priming the next transitional step. More information NIHR - Research Professorships, round 12 Funder: NIHR Closing date: 1 December 2021 The NIHR Research Professorships aim to fund research leaders of the future to promote effective translation of research and to strengthen health, public health and care research leadership at the highest academic levels. The scheme is open to all professions and all Higher Education Institutions (HEI), in partnership with NHS organisations, or other providers of health, public health and/or care services based in England, to nominate health, public health and social care researchers and methodologists with an outstanding research record of clinical and applied health research and its effective translation for improved health. Candidates must demonstrate they are on a steep career trajectory to become a research leader having spent no more than five years at their current level of seniority at the time of application. More information Davos Alzheimer's Collaborative - increasing cognitive assessment rates for older adults Funder: Davos Alzheimer's Collaborative Closing date: 1 December 2021 The Davos Alzheimer ’ s Collaborative (DAC) is funding innovators who can increase cognitive assessment rates for older adults. The proposed approach should aim to increase the percentage of patients age 65+ who are provided with a standardized cognitive assessment in selected health system(s) or implementation site(s). It should indicate which health system(s) or other implementation partner(s) your team plans work with. It can utilize any cognitive assessment solution, technology or tool with clear evidence of efficacy and potential for sustainability. DAC is agnostic on the exact mechanism for cognitive assessment. Teams can develop a novel solution or implement an existing solution. More information Psoriasis Association: Research Grants Funder: Psoriasis Association Closing date: 3 December 2021 The Psoriasis Association will consider applications that have clear relevance to its aim 'to promote and fund research into the causes, nature and care of psoriasis and to publish and disseminate the results of that research'. The Psoriasis Association offers the following: PhD studentships : Supports the training of graduate students leading to the presentation of a PhD Cecil King Memorial Award : For projects where the principal researcher is under 35 years of age, or within the first five consecutive years, at the time of application, of either their first permanent independent academic research post or a named limited-tenured/fixed-term academic research post, obtained in open competition More Information Southampton Academy of Research - training awards Funder: NIHR SoAR Closing date: 14 December 2021 SoAR funding awards 2021/2022 are now open for applications: Internship award - 6 months Transitional award - 12 months Post doctoral award - 6 or 12 months Further information is available by email NIHR - efficiency and mechanism evaluation programme - new commissioned calls Funder: NIHR Closing date: 7 December 2021 The Efficacy and Mechanism Evaluation (EME) Programme funds ambitious studies evaluating interventions with potential to make a step-change in the promotion of health, treatment of disease and improvement of rehabilitation or long-term care. Within these studies, EME supports research in the mechanisms of diseases and treatments. EME is a partnership between the Medical Research Council (MRC) and the NIHR. The EME Programme is accepting stage 1 applications to their commissioned workstream for the following funding opportunities: Mechanisms of action of health interventions Efficacy trials in regenerative medicine Early detection of disease NIHR efficacy and mechanisma evaluation programme - dementia research call Funder: NIHR Closing date: 7 December 2021 This National Institute for Health Research (NIHR) call invites proposals for dementia research to address important health and social care questions. Research could involve any aspect of prevention, diagnosis, treatment, support or care, and related health and social care services. Applications which involve investigators spanning a range of specialties are encouraged and partnership with national charities welcomed. The PHR and HTA programmes are also accepting proposals in this call - see 30 Nov and 5 Jan. More information NIHR NICE rolling call for research studies addressing NICE research recommendations Funder: NIHR Closing date: 7 December 2021 The Efficacy and Mechanism Evaluation Programme is accepting Stage 1 applications for the NICE rolling call for research studies addressing NICE research recommendations. The EME Programme is interested in receiving applications to meet recommendations in research identified in NICE guidance published from 2015 onwards (for the purposes of this call, NICE guidance includes the following: clinical, social care, public health, technology appraisals, interventional procedures and diagnostics). More information NIHR efficacy and mechanism evaluation programme - researcher-led workstream Funder: NIHR Closing date: 7 December 2021 The Efficacy and Mechanism Evaluation (EME) Programme funds ambitious studies evaluating interventions with potential to make a step-change in the promotion of health, treatment of disease and improvement of rehabilitation or long-term care. Within these studies, EME supports research in the mechanisms of diseases and treatments. EME is a partnership between the Medical Research Council (MRC) and the NIHR. The Efficacy and Mechanism Evaluation (EME) Programme is accepting stage 1 applications to their researcher-led workstream. Applications are sought for research into interventions that are based or used by the NHS and its partners. More information NIHR 21/561 James Lind Alliance Priority Setting Partnerships rolling call (EME programme) Funder: NIHR Closing date: 7 December 2021 The Efficacy and Mechanism Evaluation (EME) Programme is accepting stage 1 applications to this funding opportunity. The programme recognises the importance of the research priorities identified by the James Lind Alliance (JLA) Priority Setting Partnerships (PSP) and are interested in receiving high-quality applications which address them. More information Royal College of Surgeons of England - pump priming grants Funder: Royal College of Surgeons Closing date: 7 December 2021 The Royal College of Surgeons of England is offering a limited number of awards of up to £ 10,000 to newly appointed consultants, senior lecturers and post-doctoral trainees (appointed since 2015) in surgery who are working at hospitals and universities within the UK. The aim of the awards is to give assistance to such surgeons in the early stages of their independent research careers. Awards may be used, amongst other things, for small items of equipment, for consumables or for technical assistance. All applicants must be members or fellows of The Royal College of Surgeons of England. Applicants must be consultants, senior lecturers or post-doctoral trainees (appointed since 2015) working in surgery in the UK. More information CRUK: Early Detection and Diagnosis Project Award Funder: CRUK Closing date: 8 December 2021 Early Detection and Diagnosis Project Awards fund science to drive transformational change in how and when early cancers and pre-cancerous states are diagnosed. Early detection and diagnosis (ED&D) research seeks to detect and diagnose consequential precancerous changes and cancer at the earliest possible point at which an intervention might be made, reducing the burden of late-stage disease. ED&D projects will support discovery and translational/clinical research which is mindful of the clinical and population context. More Information NIHR i4i - product development awards, call 23 Funder: NIHR i4i Closing date: 8 December 2021 The NIHR Invention for Innovation (i4i) Programme supports the preclinical and clinical development of medical technologies in areas of existing or emerging patient need. The i4i programme invites proposals to Call 23 of its researcher-led Product Development Awards (PDA). PDAs fund the development of disruptive early-stage medical technologies that address existing or emerging healthcare needs. They support translational projects developing medical devices, in vitro diagnostics and digital health technologies that are patient-focused and for ultimate NHS use. More information Wessex REACH - peer support funding Funder: Wessex REACH Closing date: 10 December 2021 A small amount of funding is available to groups of researchers who wish to create a space for thinking, connecting and problem solving with their peers. Anyone currently working in healthcare, social care or in healthcare-related research in Wessex is eligible. Groups can apply for up to £ 500 to be used over a 1 year period. Send a short summary (up to 500 words) detailing your group, reasons for applying, planned activities, objectives and how they align with building research capacity in Wessex, and budget to info@wessexreach.org.uk . For more detail, contact Beth Stuart . More information THIS Institute environmental sustainability fellowship Funder: The Healthcare Improvement Studies (THIS) Institute Closing date: 15 December 2021 Fellowships to enable individuals to conduct research that will help the NHS increase its capacity to improve environmental sustainability. Focus areas in scope could include energy use, waste disposal, procurement and supply chains, operational processes, transport, hygiene practices, equipment and technology, care processes, device or building design, as well as many other research questions relevant to improving sustainability. Findings should be generalisable or transferable and should contribute to scholarly work as well providing real actions that can be implemented. More information CRUK: Prevention and Population Research Project Awards Funder: CRUK Closing date: 15 December 2021 Prevention and Population Research Awards provide support for focused research proposals centred on key questions in prevention and population research. More Information Closing the Gap collaboration fund Funder: UKRI Closing the Gap Network Closing date: 20 December 2021 Funding to support and encourage new and emerging collaborations in the area of severe mental ill health to develop new research proposals that could be funded through the Closing the Gap Network Plus funds or through other funding bodies. More information Action for A-T - research grants Funder: Action for A-T Closing date: 3 January 2022 Action for A-T funds medical research to speed up the process of identifying a cure for Ataxia Telangiectasia (A-T) or treatments that delay or prevent the disabling effects of this devastating childhood condition. Applications are invited for high quality research projects that have the potential to lead to treatments and cures for Ataxia-Telangiectasia. More information NIHR Health Technology Assessment Programme Researcher-led workstream Funder: NIHR Closing date: 5 January 2022 The Health Technology Assessment Programme is accepting stage 1 applications to their researcher-led evidence synthesis workstream, 21/554. More Information NIHR Health Technology Assessment Programme Researcher-led workstream Funder: NIHR Closing date: 5 January 2022 The Health Technology Assessment Programme is accepting stage 1 applications to their researcher-led workstream, 21/555. More Information NIHR 21/558 NIHR James Lind Alliance Priority Setting Partnerships rolling call (HTA Programme) Funder: NIHR Closing date: 5 January 2022 The Health Technology Assessment (HTA) Programme is accepting stage one applications to this funding opportunity. The programme recognises the importance of the research priorities identified by the James Lind Alliance (JLA) Priority Setting Partnerships (PSP) and are interested in receiving high-quality applications which address them. More Information NIHR 21/559 Dementia research call - Health Technology Assessment (HTA) Programme Funder: NIHR Closing date: 5 January 2022 The Health Technology Assessment (HTA) Programme is accepting stage one applications to this funding opportunity. Dementia is a growing challenge that has become one of the most important health and social care issues facing the world. We need to continue building the evidence base, to improve the lives of people affected by dementia. More Information NIHR Policy Research Programme - evaluation of new funding for inpatient detoxification beds Funder: NIHR Closing date: 6 January 2022 The NIHR funds policy research to enable evidence informed policy making in health and social care. The PRP Programme invites applications for a single research project to qualitatively evaluate an initiative to increase provision of inpatient detoxification to improve drug recovery. It is expected this will be based on in-depth interviews with about 30 inpatients and 30 healthcare professionals with initial contact needed in October-December 2021, a follow-up directly after the detox and a further follow-up after 6 months. The project will complement a quantitative analysis being carried out by Public Health England (PHE). More information NIHR James Lind Alliance Priority Setting Partnerships rolling call (HS&DR programme) Funder: NIHR Closing date: 11 January 2022 The Health Services and Delivery Research (HS&DR) Programme is accepting stage one applications to this funding opportunity. The programme recognises the importance of the research priorities identified by the James Lind Alliance (JLA) Priority Setting Partnerships (PSP) and are interested in receiving high-quality applications which address them and are within the scope of the programme. The JLA Priority Setting Partnerships facilitate patients, carers and clinicians to work collaboratively to identify research priorities in particular areas of health and care. Their aim is to ensure that health research funders are aware of the issues that are important to the people who need to use the research in their daily lives. The NIHR research programmes fund research across the National Health Service (NHS), public health and social care to meet the needs of those who plan, provide and receive care and services. The programmes recognise the importance of the research priorities identified by the James Lind Alliance Priority Setting Partnerships and are interested in receiving high-quality applications which address them. More information NIHR Health Services and Delivery Research Programme (standard researcher-led) Funder: NIHR Closing date: 11 January 2022 The Health Services and Delivery Research (HS&DR) Programme aims to produce rigorous and relevant evidence to improve the quality, accessibility and organisation of health and social care services. The HS&DR Programme is accepting stage 1 applications to their researcher-led workstream. The researcher-led workstream welcomes Stage 1 proposals on topics or research questions identified by researchers within the programme ’ s remit. The aim is to fund research that will lead to improvements in health services that will be of greatest benefit to the NHS and to patients. We are interested in a range of types of research including primary research and evidence synthesis. More information NIHR Invention for Innovation - challenge awards, call 13 Funder: NIHR Closing date: 12 January 2022 The Challenge Awards will fund investigations of MedTech innovations in healthcare settings. The aim is to shorten the evidence gap between the safety/efficacy typical of a newly or nearly CE-marked technology and what is required for decisions by commissioners and regulators. At the same time, this will de-risk the product for follow-on investment. Please note that nearly CE-marked technologies refers to technologies that are currently under Notified Body assessment, whereby all of the mandatory testing has been completed. More information Medical Research Foundation - adolescent dermatology Funder: Medical Research Foundation Closing date: 12 January 2022 The aim of this grant is to increase understanding of the disease mechanisms underpinning skin disorders of relevance to adolescents, and improve diagnosis, treatment and management of these diseases. MRF are inviting applications from clinicians who have the potential to be the research leaders of the future, to support research that will increase understanding of the disease mechanisms underlying adolescent skin disorders. Researchers whose work may lead to better understanding of prevention, treatment or management of these disorders are welcome to apply. More information NIHR Programme Development Grants - competition 32 Funder: NIHR Closing date: 13 January 2022 NIHR Programme Development Grants (PDG) are designed to enable a research team to carry out targeted preparatory work to develop a competitive Programme Grants for Applied Research (PGfAR) funding application. They can also be used to further develop an existing or ongoing PGfAR-funded programme of research. Programme Development Grants are designed to increase the rate and number of successful applications for a full Programme Grant by supporting the completion of the necessary preparatory work to suitably position the research team to submit a competitive Programme Grant application. Applications to PDG are made with the support of an NHS body and other providers of NHS services in England. If an application is successful, a contract will be placed with that organisation for delivery of the research and all funds for the research will be paid to the NHS organisation or other provider of NHS services. more information NIHR Population Health Career Scientist Award Funder: NIHR Closing date: 13 January 2022 The NIHR has launched the Population Health Career Scientist Award (PHCSA), a UK-wide initiative to enable senior researchers to make the next step to Reader/Professor level in their host institutions. The PHCSA forms part of a series of initiatives and investments by NIHR to enable local government to become more research active. This new award will help answer the most important research questions facing decision-makers at local and national levels to improve health and reduce inequalities. There is a desire to attract applicants representing the wide range of disciplines which undertake research in areas which impact the determinants of health (e.g. environmental science, mathematics, architecture, engineering, geography, education, social sciences, social policy, arts). More information NIHR Advanced Fellowship Funder: NIHR Closing date: 13 January 2022 The NIHR Advanced Fellowship funds post-doctoral individuals from a range of health and social care professions who have not yet been awarded a chair. Whether you are someone who has recently been or about to be awarded a PhD, or someone with several years of post-doctoral experience, you could be eligible to apply for an Advanced Fellowship. The Fellowship funds: full salary support, including protected time to concentrate on research research costs a bespoke training and development programme to meet individual needs Applicants who are active clinicians or social workers can request for up to 40% of their time to be dedicated to clinical service/development/practice, which will be covered by the Fellowship. We are particularly welcoming applications from researchers looking to undertake research in: Multiple Long Term Conditions – Multimorbidity (MLTC-M) Dementia More Information Royal Institute for Deaf People - fellowships Funder: RNID Closing date: 13 January 2022 The RNID Fellowship scheme aims to build research capacity in hearing research, by supporting the career development of the UK ’ s most talented new ‘ investigators ’ towards becoming independent scientists. Applications are invited in any of the following areas: Research to underpin the development of treatments for hearing disorders, including tinnitus . Including, but not limited to, medical devices, pharmacological treatments, genetic or cellular therapies – treatments should aim to prevent hearing loss, restore auditory function or silence tinnitus. Research to improve how new treatments for hearing disorders, including tinnitus, are developed and tested . Including research to improve the measurement of auditory function or tinnitus, or to develop models of human hearing disorders, including tinnitus. More information Cancer Research UK drug development project Funder: CRUK Closing date: 14 January 2022 Drug Development Projects are not grant funding awards. The funding is there to develop new cancer treatments from preclinical development through to early phase patient trials. Applicants must have a novel cancer agent needing preclinical and/or clinical development and have supporting in vivo efficacy data. All technology areas are considered, including small molecule, biological and other therapeutics. More information NIHR Doctoral Fellowships - round 7 Funder: NIHR Closing date: 18 January 2022 NIHR Doctoral Fellowships provide funding for individuals to undertake a PhD in an area of NIHR research. As part of the creation of the NIHR Academy, four broad Strategic Themes have been identified which represent key priority areas for the NIHR Academy. Applications received under these Themes will still have to meet the same quality threshold required for funding, but will be given priority if the number of fundable applications exceeds the maximum that can be funded. The Themes are: social care, public health, mental health and health data science. More information Parkinson's UK / Rosetree Trust joint senior research fellowship Funder: Parkinson's UK & Rosetree Trust Closing date: 19 January 2022 Parkinson's UK and Rosetrees Trust are jointly funding the Joint Senior Research Fellowship to support early career researchers with an excellent track record in novel cell culture techniques to establish a highly innovative independent drug discovery programme and become research leaders of the future. With this fellowship scheme, the funders are keen to support the progression of neuroprotective treatments for Parkinson's through the development and use of novel cell culture platforms. More information British Heart Foundation - clinical study grants Funder: British Heart Foundation Closing date: *various* see below For clinical trials and observational studies of specific patient groups, usually costing more than £ 350,000 or lasting more than 3 years. The Clinical Study Grant supports funding for: Interventional clinical trials: trials of specific interventions or pathways of care for the prevention, diagnosis and treatment of cardiovascular disease. Interventions include drugs, surgery, devices, psychological, physical and educational interventions. Observational studies of specific patient groups that are hypothesis led and address a defined clinical question(s) over a fixed timescale (up to 5 years). The population of interest should be a patient population, who will usually be recruited within the NHS. The study should have a predefined outcome(s) that will lead to changes in clinical management directly or will inform the development of a clinical trial to test an intervention. Clinical studies can include a mechanistic evaluation, either as a substudy within a clinical trial or as part of an observational study. Closing dates for proposals: 19 January 2022, 11 May 2022 More information British Heart Foundation - consultant research awards Funder: BHF Closing date: 19 January 2022 This new scheme aims to provide protected time to clinically active consultants to undertake substantial cardiovascular research activities in addition to their clinical roles. They provide up to 2 years full-time equivalent of salary support for the primary applicant, to backfill an equivalent number of NHS PAs. This grant can be taken on a full-time basis or spread across up to 5 years, and additional support costs be also be applied for in each year of an award. There will be two fixed calls for this scheme each year. More information Royal Commission for the Exhibition of 1851 - research fellowships Funder: Royal Commission 1851 Closing date: 19 January 2022 The Royal Commission for the Exhibition of 1851 awards Fellowships for advanced study and research in science, engineering, the built environment and design. 1851 Research Fellowships are intended to give early career scientists or engineers of exceptional promise the opportunity to conduct a research project of their own instigation; an ultimate objective is to contribute to the knowledge base required for a healthy and innovative national culture. Around eight awards are made each year. More information Alzheimer's Research UK - senior research fellowship Funder: Alzheimer's Research UK Closing date: 21 January 2022 Senior Research Fellowships are designed to retain excellent clinical and non-clinical researchers who have a track record of nationally competitive research, and clear plans to manage their own independent research group and become internationally recognised within the field of biomedical dementia research. The purpose of Senior Research Fellowships is to foster both clinical and non-clinical researchers in their “ transition to independence ” . Prospective applicants should a have a strong track record of original and productive research in their area (as evidenced by senior author publication(s) or other equivalent outputs), which shows productivity and impact across past appointments (typically at least one previous post-doctoral appointment). More information Alzheimer's Research UK - major projects Funder: Alzheimer's Research UK Closing date: 21 January 2022 Alzheimer ’ s Research UK is a research charity dedicated to causes, diagnosis, prevention, treatment and cure of Alzheimer ’ s. ARUK work across four key areas of action: Understand the diseases that cause dementia; diagnose people earlier and more accurately; reduce risk, backed by the latest evidence; treat dementia effectively. The Major project grant scheme provides funds for high quality research projects. It is provided to cover salaries (research, technical, students etc), equipment, animal costs and running costs (consumables, travel etc). More information NIHR Health Services & Delivery Research Programme - improving choice, access and uptake of contraception Funder: NIHR Closing date: 21 January 2022 The Health Services and Delivery Research (HS&DR) Programme aims to produce rigorous and relevant evidence to improve the quality, accessibility and organisation of health and social care services. The HS&DR Programme is interested in receiving applications to understand the impact of the pandemic on women ’ s, including transgender and non-binary people ’ s, choices, access and their attitudes and preferences towards contraception, especially towards long-acting reversible contraceptives. It is also important to understand their experiences of initial access to contraception in both general practice and sexual and reproductive health services. We are also interested in research that explores women ’ s, including transgender and non-binary people ’ s, experiences of using these services, and the extent to which their care is fragmented or well-coordinated, and what this indicates in terms of how service provision may need to change to meet future needs. Research into understanding experiences of these services in the context of rapid changes to services from face-to-face to remote during the COVID-19 pandemic is also of interest. More information Paget's Association - research grants Funder: Paget's Association Closing date: 25 January 2022 The Paget's Association is a national UK charity providing information and support to all those affected by Paget ’ s Disease of Bone. The Association funds quality research, raises awareness and supports professionals to achieve excellence in care and research. The Paget ’ s Association invites applications for Research Project Grants in all areas of Paget ’ s Disease of Bone. Collaborative research is strongly encouraged, including through our Paget ’ s Association Centres of Excellence (PACEs). More information UHS R&D small grants scheme 2021 Funder: University Hospital Southampton R&D Closing date: 26 January 2022 Grant applications are invited from investigators across the Southampton Partnership for research funding proposals that align with research portfolios within UHS clinical divisions, and/or the UHS/UoS research infrastructure. Up to £ 50k is available for projects up to three years in duration. The application form is available here . Southampton Hospitals Charity - research funding scheme Funder: Southampton Hospitals Charity Closing date: 26 January 2022 Southampton Hospitals Charity (SHC) has partnered with the Research & Development team to fund innovative research projects with the potential to demonstrate direct benefit to UHS patients. The total number of projects awarded will be determined by quality and impact. An exceptionally strong case for funding should be presented for any project costing over £ 50k. Fundraising will launch once the successful projects have been selected and projects are therefore not expected to commence until 9-12 months after award confirmation i.e., not before January 2023. All research designs, disciplines, and scope, except for basic science projects, will be considered. SHC has identified a number of research areas for this round, based on the potential for timely fundraising: cancer care cardiology child health, including neonatal neurology ophthalmology The application form is available here More information NIHR i4i - dementia: digital approaches for early detection, diagnosis and stratification Funder: NIHR Closing date: 26 January 2022 The NIHR Invention for Innovation (i4i) Programme is inviting applications for a Dementia specific funding stream aimed at the research and development of digital approaches for the early detection, diagnosis and stratification of individuals with dementia. The i4i Programme supports the research and development of innovative medical technologies that have demonstrated proof-of-concept and have a clear developmental pathway towards new products for ultimate NHS use. More information MRC Neurosciences and Mental Health - funding opportunity Funder: MRC Closing date: 26 January 2022 Apply for funding for research projects focused on neurosciences and mental health. The MRC Neurosciences and Mental Health Board funds research in neurosciences, mental health and disorders of the human nervous system. The aim is to transform understanding of the physiology and behaviour of the human nervous system throughout the life course in health and in illness, as well as how to treat and prevent disorders of the brain. The research supported by UKRI includes the interactions between the nervous system and other parts of the body, the brain, mental health and physical health. They are also interested in how episodes throughout life impact on lifelong mental and neurological health. More information Leukaemia UK - John Goldman Fellowships Funder: Leukaemia UK Closing date: 31 January 2022 Leukaemia UK John Goldman Fellowships are aimed at early career researchers with a passion for science, a desire to develop new ideas and translate scientific advances into clinical practice. Successful applicants will demonstrate that they are the potential scientific/clinical leaders of the future. Their proposed research project must be novel with the capacity to make advances in our knowledge of leukaemia and related diseases and the development of new and kinder treatments. Applications are accepted from scientists and clinician-scientists working in UK universities, research institutions or hospitals. More information Pancreatic Cancer UK - joint funded clinical research fellowship Funder: Pancreatic Cancer UK & Association of Surgeons of GB and Ireland Closing date: 31 January 2022 The Association of Surgeons of Great Britain and Ireland (ASGBI) and Pancreatic Cancer UK Fellowship: Supports a Trainee or Junior Consultant (within 5 years of first appointment) with an interest in advancing the clinical management of pancreatic cancer. This individual will visit centres of excellence abroad and bring this experience back to the NHS to advance our clinical expertise within the UK. More information British Scoliosis Research Foundation - research grants Funder: BSRF Closing date: 31 January 2022 The British Scoliosis Research Foundation (BSRF) promotes research into the treatment of scoliosis in the UK. Each year the BSRF funds a great deal of research into scoliosis and periodically holds an international symposium to spread the knowledge gained from research. BSRF Research Grants are open to appropriately qualified professionals such as scientists, clinicians, and allied health professionals (nurses, psychologists or physiotherapists). All applications will be considered, however, applicants are advised to submit their proposal under one of the following three headings: Small exploratory grant New investigation grant Major research grant More information British Infection Association - project grants Funder: British Infection Association Closing date: 31 January 2022 The BIA aims to foster excellence in all aspects of clinical infection-related research by supporting patient-facing researchers-in-training to achieve high-quality clinical and basic research in the field of infection. BIA Project Grants provide consumables costs for trainees undertaking an infection-related research project in an academic centre in the UK or Ireland. It is envisaged funds would be used to support preliminary study in a field with intention of developing the work either through a research fellowship or as an independent investigator. More information The Urology Foundation - innovation and research grant Funder: The Urology Foundation Closing date: 31 January 2022 The Urology Foundation (TUF) is dedicated to beating all urology diseases through cutting-edge research and leading education and training to ensure that fewer lives will be devastated. The Urology Foundation (TUF) will fund projects up to a value of £ 60,000 that seek to use new, exciting, innovative approaches to address urological diseases and disorders. The projects must either (a) aim to create innovative treatments or devices, (b) aim to deliver innovative care pathways or (c) aim to use innovative research techniques or methods. Please note that innovation is necessary but not sufficient for a successful application. For example, a project with innovative methodology would need to lead to a practical end point and similarly, a project aiming to design an innovative treatment would need to have a practical methodology. More information Daphne Jackson Trust and the Kennedy Trust for Rheumatology Research - rheumatology fellowship Funder: Daphne Jackson Trust & Kennedy Trust for Rheumatology Research Closing date: 31 January 2022 Applications are invited for a Kennedy Trust sponsored three year Daphne Jackson Fellowship to be held at any UK university or research establishment. The Fellowship is intended for a scientist wishing to return to research into any clinical or pre-clinical subject in the field of rheumatology and related musculoskeletal or immunological diseases More information Diabetes UK Harry Keen intermediate clinical fellowship Funder: Diabetes UK Closing date: January 2022 The Diabetes UK Harry Keen Intermediate Clinical Fellowship allows outstanding medically qualified professionals and other clinically qualified professionals – including nurses, pharmacists and members of the Allied Health Professions, who have gained a PhD or equivalent (e.g. MD (Res)) – to establish themselves as independent researchers with a view to a long-term career as a clinical research leader in the field of diabetes. It is expected that the app
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BEACON protocol v8.0 07Mar2023 signed
Description
A randomised phase IIb trial of BE AC v izumab added to Temozolomide O ± Irin tecan for children with N refractory/relapsed euroblastoma Version 8.0 dated 07-Mar-2023 Dinutuximab beta amendment Coordinating Sponsor: Sponsor Protocol Number: CAS Code: EudraCT Number: ISRCTN Reference Number: ITCC Number: Roche Study Reference Number: Email: University of Birmingham RG_ 11-087 BN2008 2012-000072-42 40708286 032 MO28245 beacon@trials.bham.ac.uk This application is supported by the facilities funded through Birmingham Science City: Translational Medicine Clinical Research Infrastructure and Trials Platform, an Advantage West Midlands (AWM) funded project which forms part of the Science City University of Warwick and University of Birmingham Research Alliance. BEACON-Neuroblastoma Protocol_vn 8.0_vd 07Mar2023 Page1 of 157 BEACON-Neuroblastoma Trial Protocol AMENDMENTS The following amendments and/or administrative changes have been made to this protocol since the implementation of the first approved version Amendment Date of number amendment Protocol version number Type of amendment SA 1 29-Jan-2013 2.0 Substantial Amendment N/A 23-Apr-2013 2.0a Non-Substantial Amendment N/A 01-Jul-2013 2.0b Non-Substantial Amendment Summary of amendment Introduction of the recommendation of weekly monitoring of blood counts for all patients receiving irinotecan. Addition of planned vaccination with live vaccination to exclusion criteria and prohibited medications section. ITCC Number has been corrected. Roche Study Reference Number and ISRCTN Reference Number have been added. Contact details for Plasma & Tumour Angiogenesis-Related Biomarkers have been amended. Table numbers have been corrected. Addition of guidance for research bone marrow sampling in Schedule of Activities table and sections 7.4.2.2 and 7.5.2. Addition of paragraph to sections 7.2, 7.6.1 – 7.6.4 detailing arrangements for handling dose modifications for Irinotecan + Temozolomide for patients receiving Bevacizumab. Discontinuation rules for osteonecrosis of the jaw and eye disorders added to table 13 in section 7.6.4. Correction to table number references in section 7.6.3. Clarification made in section 13.4.1 concerning Planned Interim Analysis. SA 3 06-Oct-2014 4.0 Substantial Amendment Changes to the Trial Personnel section of the protocol to include the addition of contact details for Denmark and Ireland Lead Investigators. Amendments to reflect the changes in study sampling requirements to Trial Synopsis, Schedule of Activities table and sections 1.2.6, 2.1, 2.2, 5.1, 5.2, 7.3, 7.4.2 and 7.5. Amendment to exclusion criteria in Trial Synopsis and section 4.2. Changes to the Schedule of Activities table to include the addition of an echocardiogram to be performed at screening and Tanner staging at screening and yearly in follow up. Changes to the time line for measuring renal function prior to commencing treatment in the Trial Synopsis, Schedule of Activities and section 4.1. BEACON-Neuroblastoma Protocol_vn 8.0_vd _07Mar2023 Page 3 of 157 BEACON-Neuroblastoma Trial SA 4 06-Oct-2014 4.0 SA 5 30-Jul-2015 5.0 Substantial Amendment Substantial Amendment Protocol Option to fax emergency randomisation removed. Telephone only in section 6.2 Changes to guidelines in section 7.2 for dose calculation in patients whose weight exceeds the 98th centile for age. Removal of enhanced data collection for Adverse Events of Special Interest (AESI) in section 7.6 and 9.1.2. Addition of option to extend treatment delay with agreement from Sponsor in Section 7.6.1 Addition of necrotising fasciitis as an adverse event requiring bevacizumab discontinuation in section 7.6.4. Changes to section 7.10 concerning the documenting of concomitant medications in patient medical notes and administration of bisphosphonates. Changes to section 9.1 regarding reporting of laboratory adverse events. Clarification on the arrangements for Follow Up Form completion for patients who do not require further follow up visits in section 11. Changes to bevacizumab and irinotecan preparation and dispensing guidelines in sections 8.2.4 and 8.3.3. Clarification on fasting arrangements prior to temozolomide administration added to section 8.4.3. Changes to events that should be reported on an Expected SAR Form in section 9.1.3.1. Clarification on SAEs that should be reported to F.Hoffman-La Roche Ltd in section 9.2.6 Addition of Trial Management Group meeting frequency in section 14.4. Changes to the wording of irinotecan randomisation in section 13.4.2. Addition of guidelines for dose reduction and discontinuation of temozolomide for liver toxicity in tables 8, 9, 10 & 11. Reference to the National Coordinating Centres has been changed to National CoSponsor throughout. Reference to Sponsor has been changed to Coordinating Sponsor. Change of Chief Investigator to Professor Pamela Kearns. Change of Principal Investigator at Royal Marsden Hospital to Dr Sucheta Vaidya. No changes made to the Protocol version. Chief Investigator and UK Lead Investigator changed to Dr Lucas Moreno Switzerland details added Schedule of events table amended for End Of Treatment clarity BEACON-Neuroblastoma Protocol_vn 8.0_vd _07Mar2023 Page 4 of 157 BEACON-Neuroblastoma Trial N/A 23-Sep-2015 5.0a SA 6 16-Jan-2019 6.0a Protocol Topotecan added to the study as a new trial question and 2 new randomisation arms. The following sections are amended accordingly: Synopsis (Primary Objectives, sample size, Trial Duration, Trial therapy) Section 1 Background and rationale (Trial rationale) Section 3 Trial design (Randomisation) Section7.1 and 7.2 Treatment details Section7.6.1 Dose modifications Table 6 amended, Tables 11 and 12 added Section 8.4 Pharmaceutical Information Section 13 Statistical considerations The following changes were made to the Eligibility: Inclusion criteria – further details regarding birth control Exclusion criteria – Defined wash out period following prior IMP according to IMP half-life or 14 days. Lifestyle guidelines - further details regarding birth control Section 7.6 Dose modifications Figure 1 – reference to “chemo” changed to Temozolomide/Irinotecan/Topotecan” for clarity Section 8.2.4 Reference to “chemo” removed for clarity Section 7.6.4 AEs requiring Bevacizumab discontinuation – additional AEs added following Bevacizumab IB v22 Addendum Additional mRNA and exploratory sampling. Non-Substantial Amendment Substantial amendment The requirement for confirmatory scans was removed from the Schedule of Activities and Response assessment section 7.4.3. Lead Investigator for France amended to Dr Marion Gambart Minor wording corrections and clarifications Schedule of events table corrected Introduction of two new treatment arms (dinutuximab beta) for additional 64 patients Addition of eligibility criteria, schedule of events, treatment details, duration, cross over and dose modification details for new dinutuximab beta arms Adaptation of objectives, trial design, supporting treatment, pharmaceutical information and statistical consideration sections with new, relevant information. BEACON-Neuroblastoma Protocol_vn 8.0_vd _07Mar2023 Page 5 of 157 BEACON-Neuroblastoma Trial N/A 11-Apr-2019 6.0b SA 7 07-Feb-2020 7.0 SA 22 07-Mar-2023 8.0 Protocol Non-Substantial Amendment Substantial Amendment Substantial Amendment Minor wording corrections and clarifications Version amended from 6.0 to 6.0a to add. Additional rationale to update typographical errors.) Trial Synopsis: Clarification of recruitment targets Clarification of Section 10 title: “Dinutuximab beta and topotecan randomisations” Clarification that not all biological studies will be open at any one time (Section 10.2 and 15.5) Minor wording corrections and clarifications Urgent Safety Measure – implemented on 28th January 2020 Closure of Temozolomide (T) and Dinutuximab beta and Temozolomide (dBT) arms with immediate effect. Section 1.1 Background Section 1.2.3 Benefit Risk assessment Section 3.1 Randomisation Section 10 Headings changed Section 10.3 Trial therapy Update of contact details Change of definition of End of Trial (Section 21). Protocol previously defined two stages of end of trial (6 months after last patient completes treatment and 12 months after last data capture after 5 years follow up). This has been combined into one End of Trial definition: 6 months after last patient last visit (i.e. after 5 years follow up) Also addition of option to email SAE form (Section 18.2.1.2) BEACON-Neuroblastoma Protocol_vn 8.0_vd _07Mar2023 Page 6 of 157 BEACON-Neuroblastoma Trial Protocol TRIAL PERSONNEL Chief Investigator: Co-Investigators: Exploratory Biomarkers Dr Lucas Moreno Dr. Lucas Moreno, MD, PhD Director Paediatric Oncology & Haematology Division Vall d’Hebron Barcelona Hospital Campus Passeig de la Vall d’Hebron, 119-129, 08035, Barcelona, Spain +34 93 489 3000 +34 93 489 4060 lucas.moreno@vhebron.net Professor Keith Wheatley Professor of Clinical Trials Cancer Research UK Clinical Trials Unit (CRCTU) Institute of Cancer and Genomic Sciences College of Medical and Dental Sciences University of Birmingham Birmingham, UK B15 2TT +44 (0)121 415 9119 k.wheatley@bham.ac.uk Dr Juliet Gray Associate Professor and Consultant in Paediatric Oncology Southampton Children’s Hospital Tremona Road Southampton SO16 6YD +44 (0) 790 1507929 juliet.gray@uhs.nhs.uk Dr Gudrun Schleiermacher Senior Scientist Institute Curie 26 rue d'Ulm 75248 Paris cedex 05 France +33 (0)1 56 24 45 50 +33 (0)1 56 24 66 30 gudrun.schleiermacher@curie.net Professor Louis Chesler Paediatric Tumour Biology Team Institute of Cancer Research and Royal Marsden Hospital (University of London), Downs Road, Sutton Surrey, UK SM2 5PT +44 (0) 208 722 4035 BEACON-Neuroblastoma Protocol_vn 8.0_vd _07Mar2023 Page 7 of 157 BEACON-Neuroblastoma Trial Protocol louis.chesler@icr.ac.uk Functional Imaging Study: Professor Andrew Peet Institute of Child Health University of Birmingham Whittall Street Birmingham, UK B4 6NH +44 (0) 121 333 8234 +44 (0) 121 333 8241 a.peet@bham.ac.uk Dr Dow-Mu Koh Consultant Radiologist in Functional Imaging Royal Marsden Hospital Downs Road, Sutton, Surrey, UK SM2 5PT +44 (0) 208 6613857 dow-mu.koh@icr.ac.uk Professor Martin Leach Co-Director, Cancer Research UK and EPSRC Centre for Cancer Imaging, Director, NIHR Clinical Research Facility Deputy Head, Division of Radiotherapy and Imaging Institute of Cancer Research and Royal Marsden Hospital (University of London), Downs Road, Sutton Surrey, UK SM2 5PT +44 (0 208 661 3338 Martin.Leach@icr.ac.uk Molecular Monitoring mRNA Study: Professor Sue Burchill Leeds Institute of Cancer & Pathology St. James University Hospital Beckett Street Leeds, UK LS9 7TF +44 (0) 113 206 5873 +44 (0) 113 242 9886 S.A.Burchill@leeds.ac.uk Professor Walter Gregory Clinical Trials Research Unit (CTRU) University of Leeds Clinical Trials Research House 71-75 Clarendon Road Leeds LS2 9PH +44 (0) 113 343 1489 +44 (0) 113 343 1471 BEACON-Neuroblastoma Protocol_vn 8.0_vd _07Mar2023 Page 8 of 157 BEACON-Neuroblastoma Trial Protocol Trial Statistician: Trial Coordinator & Trial Office: Randomisation Service: SAE Reporting: W.M.Gregory@leeds.ac.uk Miss Grace Holt Cancer Research UK Clinical Trials Unit (CRCTU) Institute of Cancer and Genomic Sciences College of Medical and Dental Sciences University of Birmingham Birmingham, UK B15 2TT +44 (0)121 414 8328 +44 (0)121 414 3700 G.C.Holt@bham.ac.uk Miss Punam Mistry Children’s Cancer Trials Team Cancer Research UK Clinical Trials Unit (CRCTU) Institute of Cancer and Genomic Sciences College of Medical and Dental Sciences University of Birmingham Birmingham, UK B15 2TT +44 (0)121 414 3788 +44 (0)121 414 9520 beacon@trials.bham.ac.uk Provided by the CRCTU at the University of Birmingham Randomisation should be performed by sites online at: https://www.cancertrials.bham.ac.uk/BEACONLive In case of any problems with online randomisation, randomisation can be performed over the phone by the CRCTU on: 0800 371 969 or +44 (0)121 414 3366 SAEs should be faxed to the BEACON-Neuroblastoma Trial Office, CRCTU, University of Birmingham, UK + 44 (0)121 414 9520 or +44 (0)121 414 3700 National Coordinating Investigators: Austria – Lead Investigator: Prof Dr Ruth Ladenstein St. Anna Children’s Hospital and CCRI /Studies and Statistics Department for Integrated Research and Projects (S²IRP) Kinderspitalgasse 6, Zimmermannplatz 10 A-1090 Vienna Austria +43-1-40470-4750 +43-1- 40470- 7430 ruth.ladenstein@ccri.at BEACON-Neuroblastoma Protocol_vn 8.0_vd _07Mar2023 Page 9 of 157 BEACON-Neuroblastoma Trial Belgium Lead Investigator: Prof Genevieve Laureys Ghent University Hospital 9000 Ghent De Pinterlaan 185 Belgium +32 93 32 34 48 genevieve.laureys@uzgent.be Denmark – Lead Investigator: Dr Karsten Nysom Dept. of Paediatrics & Adolescent Medicine Rigshospitalet Blegdamsvej 9 DK2100 Copenhagen Denmark +45 35 45 08 09 +45 35 45 50 55 Karsten.nysom@regionh.dk France – Lead Investigator: Dr Marion Gambart Unité d'Hémato-Oncologie Hôpital des Enfants 330, avenue de Grande Bretagne TSA 70034 31059 Toulouse Cedex France +33 (0)5 34 55 86 11 +33 (0)5 34 55 86 12 gambart.m@chu-toulouse.fr Germany - Lead Investigator: Dr. Simone Hettmer Zentrum für Kinder- und Jugendmedizin UNIVERSITÄTSKLINIKUM FREIBURG Mathildenstr. 1, 79106 Freiburg Germany +49 761 270-43000 +49 761 270-45180 simone.hettmer@uniklinik-freiburg.de Ireland – Lead Investigator: Dr Cormac Owens Our Lady’s Children’s Hospital Crumlin Road, Crumlin Dublin 12 Ireland +35314096659 +35313453041 Cormac.owens@olchc.ie Protocol BEACON-Neuroblastoma Protocol_vn 8.0_vd _07Mar2023 Page 10 of 157 BEACON-Neuroblastoma Trial Protocol Italy – Lead Investigator: Dr. Aurora Castellano U.O.Oncoematologia Ospedale Pediatrico Bambino Gesù Pzza S. Onofrio 4 00165 Roma Italy +39 06 68592957-2678 +39 06 68592826 aurora.castellano@opbg.net Netherlands – Lead Investigator: Dr. C Michel Zwaan Erasmus Medical Center Sophia’s Children's Hospital Dr. Molewaterplein 60 3015 GJ Rotterdam +31 (0) 10 703 6691 +31(0) 10 703 6681 c.m.zwaan@erasmusmc.nl Spain – Lead Investigator: Dr. Victoria Castel Instituto de Investigación Sanitaria Unidad de Oncología Pediátrica Hospital Universitario La Fe Bulevar Sur, S/N 46026 Valencia Spain +34 963862758 Ext 50040 +34 963494416 castel_vic@gva.es Switzerland – Lead Investigator: Dr. Nicolas Gerber University Children’s Hospital, Steinwiesstrasse 75, CH-8032 Zurich, Switzerland +41 44 266 31 17 +41 44 266 34 61 Nicolas.gerber@kispi.uzh.ch UK – Lead Investigator: Dr Lucas Moreno Honorary Research Fellow University of Birmingham Birmingham, UK B15 2TT +44 (0)121 414 3788 +44 (0)121 414 9520 lucas.moreno@vhebron.net, lmorenom@ext.cnio.es BEACON-Neuroblastoma Protocol_vn 8.0_vd _07Mar2023 Page 11 of 157 BEACON-Neuroblastoma Trial Protocol TRIAL SYNOPSIS Title A randomised phase IIb trial of bevacizumab added to temozolomide ± irinotecan for children with refractory/relapsed neuroblastoma – BEACON-Neuroblastoma Trial Trial Design A phase II, randomised, open label, international multicentre 3x2 factorial trial. The dinutuximab beta amendment did utilise a 2x2 factorial design it will now be a simple two-way randomisation. Objectives Primary: - To test whether bevacizumab added to a backbone chemotherapy regimen (temozolomide, irinotecan + temozolomide or temozolomide + topotecan) demonstrates activity in children with relapsed or refractory neuroblastoma - To test whether the addition of irinotecan to temozolomide increases the activity of chemotherapy in children with relapsed or refractory neuroblastoma - To test whether the addition of topotecan to temozolomide increases the activity of chemotherapy in children with relapsed or refractory neuroblastoma (“topotecan randomisation”) - To test whether dinutuximab beta added to a backbone chemotherapy regimen (temozolomide or temozolomide + topotecan) demonstrates activity in children with relapsed or refractory neuroblastoma (“dinutuximab beta randomisation”) Secondary: - To evaluate the safety of the regimens Tertiary: - To undertake preliminary evaluation of the changes in magnetic resonance imaging (MRI) derived functional imaging biomarkers of angiogenesis - To undertake preliminary evaluation of the role of circulating mRNA levels for tyrosine hydroxylase (TH), paired-like homeobox 2b (PHOX2B) and doublecortin (DCX) as prognostic/predictive biomarkers in this refractory/relapsed setting - To undertake a preliminary evaluation of the role of tumour molecular profiles in blood and archival tumour tissue profiles as prognostic and predictive biomarkers - To undertake a preliminary evaluation of biomarkers of response to anti-GD2 therapy (Fc/KIR polymorphisms, Antibody Dependant Cell-Mediated Cytotoxicity (ADCC) and Anti-Drug Antibodies (ADAs) and of dinutuximab beta pharmacokinetics (PK) Outcome Measures Primary Endpoint: - Best response (Complete Response [CR] or Partial Response [PR]) [1] at any time during the first 6 cycles of trial treatment - For the bevacizumab part 2 only: Progression-free survival (PFS) Secondary Endpoints: - Safety of the regimens: Incidence and severity of Adverse Events (AE)s - PFS - Overall survival (OS) - Event-free survival (EFS) BEACON-Neuroblastoma Protocol_vn 8.0_vd _07Mar2023 Page 12 of 157 BEACON-Neuroblastoma Trial Protocol Exploratory/Tertiary Endpoints: - Changes in (MRI) derived functional imaging biomarkers of angiogenesis measured by quantitative dynamic contrast enhanced (DCE) MRI: primary biomarkers will be the transfer constant Ktrans [min-1] and initial area under the gadolinium uptake curve from 0 to 60 seconds (IAUGC60, mM Gd min) and secondary biomarkers will be tumour apparent diffusion coefficient (ADC, 10-6 cm2 s-1), native T1 and T2 relaxation times (ms) and transverse relaxation rate R2* - Changes in circulating mRNA levels for TH, PHOX2B and DCX in bone marrow and blood samples - Pilot descriptive study of angiogenesis and neuroblastoma markers that may include O6methylguanine-methyltransferase (MGMT) status, immunohistochemistry and immunofluorescence markers on tumour samples (such as microvessel density (MVD), CD31, Ki67, NRP1, VEGFR-1, VEGFR-2, C-KIT), DNA/RNA extraction from tissue sections for tumour mutation screening and tumour expression profiling - A preliminary correlation of the different biomarkers [Fc/KIR polymorphisms, Antibody – Dependent Cellular Toxicity (ADCC), and Anti-Drug Antibodies (ADAs)] will be made with parameters of anti-tumour activity (response rate, PFS and OS). PK parameters (dinutuximab beta trough levels) for this chemo-immunotherapy regimen will be described. Patient Population Children and young adults aged 1 to 21 years of age with relapsed/refractory neuroblastoma. Sample Size Approximately 224 patients, including 160 for the bevacizumab randomisation and 64 for the dinutuximab beta amendment. Trial Duration 8 years of patient recruitment, 5 years of patient follow up BEACON-Neuroblastoma Protocol_vn 8.0_vd _07Mar2023 Page 13 of 157 BEACON-Neuroblastoma Trial Protocol Abbreviations ADA ANTI-DRUG ANTIBODIES ADCC ANTIBODY – DEPENDENT CELL-MEDIATED CYTOTOXICITY AE ADVERSE EVENT AESI ADVERSE EVENT OF SPECIAL INTEREST AFSAPPS COMPETENT AUTHORITY FOR FRANCE ALT ALANINE AMINOTRANSFERASE ANC ABSOLUTE NEUTROPHIL COUNT APPT ACTIVATED PARTIAL THROMBOPLASTIN TIME ASCT AUTOLOGOUS STEM CELL TRANSPLANTATION AST ASPARTATE AMINOTRANSFERASE AUC AREA UNDER THE CURVE AR ADVERSE REACTION BIT BEVACIZUMAB + IRINOTECAN + TEMOZOLOMIDE ARM BM BONE MARROW BP BLOOD PRESSURE BSA BODY SURFACE AREA BT BEVACIZUMAB + TEMOZOLOMIDE ARM BTTo BEVACIZUMAB + TEMOZOLOMIDE + TOPOTECAN ARM CI CHIEF INVESTIGATOR CIs CONFIDENCE INTERVALS COG CHILDREN’S ONCOLOGY GROUP CNS CENTRAL NERVOUS SYSTEM CR COMPLETE RESPONSE CRF CASE REPORT FORM CR UK CANCER RESEARCH UK CRCTU CANCER RESEARCH UK CLINICAL TRIALS UNIT (UNIVERSITY OF BIRMINGHAM) CRN CLINICAL RESEARCH NETWORK CSR CLINICAL STUDY REPORT CT COMPUTERISED TOMOGRAPHY CTC COMMON TERMINOLOGY CRITERIA CTCAE COMMON TERMINOLOGY CRITERIA FOR ADVERSE EVENTS CXR CHEST X-RAY dBT DINUTUXIMAB BETA + TEMOZOLOMIDE ARM dBTTo DINUTUXIMAB BETA + TEMOZOLOMIDE + TOPOTECAN ARM DCX DOUBLECORTIN DLT DOSE LIMITING TOXICITY DMC DATA MONITORING COMMITTEE DNA DEOXYRIBONUCLEIC ACID ECHO ECHOCARDIOGRAM ECOG EASTERN COOPERATIVE ONCOLOGY GROUP EFS EVENT FREE SURVIVAL EMA EUROPEAN MEDICINES AGENCY ERDC ELECTRONIC REMOTE DATA CAPTURE EOT END OF TREATMENT FFPE FORMALIN-FIXED PARAFFIN EMBEDDED GCP GOOD CLINICAL PRACTICE G-CSF GRANULOCYTE COLONY STIMULATING FACTOR BEACON-Neuroblastoma Protocol_vn 8.0_vd _07Mar2023 Page 14 of 157 BEACON-Neuroblastoma Trial Protocol GFR GM-CSF GGT GP GPOH HR IB ICF ICH IMP INR INRC INRG INSS IRF ISF IT ITCC IV MGMT MIBG MHRA MRD MRI MSKCC MTD MYCN NANT NCI NCS NR OS OTC PCP PD PFS PHOX2B PI PIS PK PMA PRES PO PPTP PR REC RECIST RNA GLOMERULAR FILTRATION RATE GRANULOCYTE-MONOCYTE COLONY STIMULATING FACTOR GAMMA-GLUTAMYL TRANSPEPTIDASE GENERAL PRACTITIONER GERMAN SOCIETY FOR PAEDIATRIC ONCOLOGY & HAEMATOLOGY HEART RATE INVESTIGATOR BROCHURE INFORMED CONSENT FORM INTERNATIONAL CONFERENCE ON HARMONISATION INVESTIGATIONAL MEDICINAL PRODUCT INTERNATIONAL NORMALISED RATIO INTERNATIONAL NEUROBLASTOMA RESPONSE CRITERIA INTERNATIONAL NEUROBLASTOMA RISK GROUP INTERNATIONAL NEUROBLASTOMA STAGING SYSTEM INSTITUTIONAL REVIEW BOARD INVESTIGATOR SITE FILE IRINOTECAN + TEMOZOLOMIDE ARM INNOVATIVE THERAPIES FOR CHILDREN WITH CANCER INTRAVENOUS O6-METHYGUANINE METHYLTRANSFERASE META-IODO-BENZYL-GUANIDINE MEDICINES AND HEALTHCARE PRODUCTS REGULATORY AGENCY MINIMAL RESIDUAL DISEASE MAGNETIC RESONANCE IMAGING MEMORIAL SLOAN KETTERING CANCER CENTRE MAXIMUM TOLERATED DOSE MYELOCYTOMATOSIS VIRAL RELATED ONCOGENE NEW AGENTS FOR NEUROBLASTOMA THERAPY NATIONAL COORDINATING INVESTIGATOR NATIONAL CO-SPONSOR NO RESPONSE OVERALL SURVIVAL OVER THE COUNTER PNEUMOCYSTIS CARNI PNEUMONITIS PROGRESSSIVE DISEASE PROGRESSION FREE SURVIVAL PAIRED-LIKE HOMEOBOX2B PRINCIPAL INVESTIGATOR PATIENT INFORMATION SHEET PHARMACOKINETICS POPULATION-MODELLING ANALYSIS POSTERIOR REVERSIBLE ENCEPHALOPATHY SYNDROME ORALLY PAEDIATRIC PRECLINICAL TESTING PROGRAM PARTIAL RESPONSE RESEARCH ETHICS COMMITTEE RESPONSE EVALUATION CRITERIA IN SOLID TUMOURS RIBONUCLEIC ACID BEACON-Neuroblastoma Protocol_vn 8.0_vd _07Mar2023 Page 15 of 157 BEACON-Neuroblastoma Trial Protocol RTKI RT-qPCR SAE SAR SCT SD SFOP SIOPEN SNP SPC SUSAR SWFI T TH TMA TMG TSC TTo TVD UAR UKCCSG ULN VTE VEGF VGPR WMA RECEPTOR TYROSINE KINASE INHIBITORS REVERSE TRANSCRIPTASE QUANTITATIVE POLYMERASE CHAIN REACTION SERIOUS ADVERSE EVENT SERIOUS ADVERSE REACTION STEM CELL TRANSPLANT STABLE DISEASE FRENCH SOCIETY OF PAEDIATRIC ONCOLOGY INTERNATIONAL SOCIETY PAEDIATRIC ONCOLOGY EUROPEAN NEUROBLASTOMA GROUP SINGLE NUCLEOTIDE POLYMORPHISM SUMMARY OF PRODUCT CHARACTERISTICS SUSPECTED UNEXPECTED SEVERE ADVERSE REACTION STERILE WATER FOR INJECTION TEMOZOLOMIDE ARM TYROSINE HYDROXYLASE TISSUE MICROARRAY TRIAL MANAGEMENT GROUP TRIAL STEERING COMMITTEE TEMOZOLOMIDE + TOPOTECAN ARM TOPOTECAN, VINCRISTINE & DOXORUBICIN UNEXPECTED ADVERSE REACTION UNITED KINGDOM CHILDREN’S CANCER STUDY GROUP UPPER LIMIT OF NORMAL VENOUS THROMBO-EMBOLISM VASCULAR ENDOTHELIAL GROWTH FACTOR VERY GOOD PARTIAL RESPONSE WORLD MEDICAL ASSOCIATION FORMULAE Mosteller formula: BSA (m²) = BEACON-Neuroblastoma Protocol_vn 8.0_vd _07Mar2023 Page 16 of 157 BEACON-Neuroblastoma Trial Protocol Table of Contents Trial Synopsis ...................................................................................................................................... 12 Title .................................................................................................................................................... 12 Trial Design ........................................................................................................................................ 12 Objectives .......................................................................................................................................... 12 Outcome Measures............................................................................................................................ 12 Patient Population .............................................................................................................................. 13 Sample Size ....................................................................................................................................... 13 Trial Duration...................................................................................................................................... 13 Abbreviations ..................................................................................................................................... 14 1. Background and Rationale ............................................................................................................. 22 1.1 Background............................................................................................................................ 22 1.1.1 Background for the dinutuximab beta amendment............................................................ 28 1.2 Trial Rational.......................................................................................................................... 29 1.2.1 Justification for design ....................................................................................................... 29 1.2.2 Rationale for patient population ......................................................................................... 30 1.2.3 Benefit-risk assessment .................................................................................................... 31 1.2.4 Rationale for the selected backbone schedules: Temozolomide, irinotecan + temozolomide and temozolomide + topotecan .............................................................................. 31 1.2.5 Rationale for dosing schedule of bevacizumab................................................................. 32 1.2.6 Rationale for evaluating chemo-immunotherapy in the BEACON-Neuroblastoma Trial... 32 1.2.7 Rationale for dosing schedule of dinutuximab beta........................................................... 33 1.2.8 Rationale for the use of biomarker studies ........................................................................ 34 1.3 Relevance and future importance ......................................................................................... 35 2. Objectives and Outcome Measures ............................................................................................. 36 2.1 Objectives .............................................................................................................................. 36 2.2 Outcome Measures ............................................................................................................... 37 3. Trial Design ..................................................................................................................................... 37 3.1 Randomisation....................................................................................................................... 37 3.2 Duration of treatment............................................................................................................. 38 3.3 Frequency and duration of follow-up ..................................................................................... 38 4. Eligibility.......................................................................................................................................... 39 4.1 Lifestyle guidelines ................................................................................................................ 39 5. Schedule of activities..................................................................................................................... 39 6. Screening and Consent ................................................................................................................. 40 6.1 Informed Consent .................................................................................................................. 40 6.2 Screening............................................................................................................................... 41 7. Trial Entry........................................................................................................................................ 42 7.1 Procedure for online patient randomisation........................................................................... 42 7.2 Emergency Randomisation ................................................................................................... 42 8. Treatment Details ........................................................................................................................... 43 8.1 Definition of Investigational Medicinal Products (IMPs) ........................................................ 43 9. Bevacizumab randomisation......................................................................................................... 43 9.1 Eligibility criteria for the bevacizumab randomisation............................................................ 43 9.1.1 Inclusion criteria for the bevacizumab randomisation ....................................................... 43 9.1.2 Exclusion criteria for the bevacizumab randomisation ...................................................... 44 9.2 Schedule of activities for the bevacizumab randomisation ................................................... 45 BEACON-Neuroblastoma Protocol_vn 8.0_vd _07Mar2023 Page 17 of 157 BEACON-Neuroblastoma Trial Protocol 9.3 Trial Therapy (bevacizumab randomisation) ......................................................................... 49 9.3.1 Bevacizumab randomisation trial treatment ...................................................................... 49 9.4 Treatment Schedule..................................................................................................................... 51 9.4.1 Day 1 of Cycle 1 ................................................................................................................ 51 9.4.2 Day 1 of subsequent cycles............................................................................................... 51 9.4.3 Post Cycle 6 (For patients continuing to Cycle 7-12) ........................................................ 52 9.4.4 End of Treatment ............................................................................................................... 52 9.4.5 Treatment Duration............................................................................................................ 52 9.5 Dose Modifications for the bevacizumab randomisation ....................................................... 53 9.5.1 Dose Modifications for AEs due to chemotherapy - for the bevacizumab randomisation. 56 9.5.2 Bevacizumab – Infusion-related Reaction/Infusional Site Extravasation Management Guidelines ...................................................................................................................................... 62 9.5.3 Bevacizumab - Treatment Delays ..................................................................................... 63 9.5.4 Bevacizumab - Discontinuation ........................................................................................ 64 9.5.5 Bevacizumab - Toxicity Management guidelines .............................................................. 65 9.6 Central Venous Access Device (CVAD)................................................................................ 67 10 Dinutuximab beta and topotecan randomisations...................................................................... 68 10.1 Eligibility for the dinutuximab beta randomisation ................................................................. 68 10.1.1 Inclusion criteria for the dinutuximab beta randomisation ............................................. 68 10.1.2 Exclusion criteria for the dinutuximab beta randomisation ............................................ 69 10.2 Schedule of events for the dinutuximab beta and topotecan randomisations....................... 70 10.3 Trial therapy (dinutuximab beta and topotecan randomisations) .......................................... 74 10.3.1 Dinutuximab beta and topotecan trial treatment................................................................ 75 10.4 Treatment Schedule .............................................................................................................. 76 10.4.1 Day 1 of Cycle 1 ............................................................................................................ 76 10.4.2 Day 1 of subsequent cycles........................................................................................... 76 10.4.3 Post Cycle 6 (For patients continuing to Cycle 7-12 on chemotherapy only) ............... 77 10.4.4 End of Treatment ........................................................................................................... 77 10.4.5 Treatment Duration............................................................................................................ 78 10.4.6 Cross-over ......................................................................................................................... 78 10.5 Dose Modifications – dinutuximab beta and topotecan randomisations ............................... 79 10.5.1 Dose modifications for dinutuximab beta specific toxicities .......................................... 79 10.5.2 Dose modifications for haematological toxicity.............................................................. 81 10.5.3 Dose modifications for hepatic toxicity .......................................................................... 82 11 Treatment Compliance................................................................................................................... 84 12 Supportive Treatment .................................................................................................................... 84 12.1 Nausea and Vomiting ............................................................................................................ 84 12.2 Growth Factors ...................................................................................................................... 84 12.3 Fever and neutropenia .......................................................................................................... 84 12.4 Blood products....................................................................................................................... 84 12.5 Pneumocystis jirovecii pneumonia (PJP) prophylaxis ........................................................... 84 12.6 Management of side effects caused by non-selective NSAIDs as cyclooxygenase (COX) type I and II inhibitors ......................................................................................................................... 84 12.7 Supportive care during Dinutuximab beta infusion................................................................ 85 12.7.1 Pain Management.......................................................................................................... 85 12.7.2 Prevention of dinutuximab beta related infusion reactions............................................ 86 13 Concomitant Medication................................................................................................................ 87 14 Assessments .................................................................................................................................. 87 BEACON-Neuroblastoma Protocol_vn 8.0_vd _07Mar2023 Page 18 of 157 BEACON-Neuroblastoma Trial Protocol 14.1 Response assessment .......................................................................................................... 88 15 Biomarkers...................................................................................................................................... 88 15.1 Blood sampling safety ........................................................................................................... 88 15.2 MRI-derived functional imaging biomarkers of angiogenesis................................................ 90 15.3 Molecular monitoring mRNA.................................................................................................. 90 15.4 Neuroblastoma exploratory biomarker analyses ................................................................... 90 15.5 Sample Collection.................................................................................................................. 92 15.5.1 Peripheral blood samples .............................................................................................. 92 15.5.2 Bone Marrow Samples .................................................................................................. 92 15.5.3 Archival tumour samples ............................................................................................... 92 16 Patient Follow Up ........................................................................................................................... 93 16.1 Patient Withdrawal................................................................................................................. 93 17 Pharmaceutical Information .......................................................................................................... 94 17.1 Definition of Investigational Medicinal Product ...................................................................... 94 17.2 Bevacizumab ......................................................................................................................... 94 17.2.1 Bevacizumab - Drug Supply .......................................................................................... 94 17.2.2 Bevacizumab - Ordering ............................................................................................... 94 17.2.3 Bevacizumab - Formulation, Packaging and Labelling ................................................. 94 17.2.4 Bevacizumab - Preparation and Dispensing ................................................................. 95 17.2.5 Compatibility information ............................................................................................... 95 17.2.6 Bevacizumab - Administration ....................................................................................... 95 17.2.7 Bevacizumab – Accountability....................................................................................... 96 17.2.8 Bevacizumab - Destruction............................................................................................ 96 17.3 Cyclophosphamide ................................................................................................................ 96 17.4 Dinutuximab beta................................................................................................................... 96 17.5 Irinotecan ............................................................................................................................... 96 17.5.1 Irinotecan - Drug Supply ............................................................................................... 96 17.5.2 Irinotecan - Formulation, Packaging and Labelling ....................................................... 96 17.5.3 Irinotecan - Preparation and Dispensing ....................................................................... 97 17.5.4 Compatibility information ............................................................................................... 97 17.5.5 Irinotecan - Administration ............................................................................................. 97 17.6 Temozolomide ....................................................................................................................... 97 17.6.1 Temozolomide – Drug Supply ....................................................................................... 97 17.6.2 Temozolomide - Formulation, Packaging and Labelling ............................................... 97 17.6.3 Temozolomide - Administration ..................................................................................... 97 17.7 Topotecan.............................................................................................................................. 98 17.7.1 Topotecan - Drug Supply.............................................................................................. 98 17.7.2 Topotecan - Formulation, Packaging and Labelling ..................................................... 98 17.7.3 Topotecan - Preparation and Dispensing ..................................................................... 98 17.7.4 Topotecan - Compatibility information ........................................................................... 98 17.7.5 Topotecan - Administration........................................................................................... 99 18 Adverse Event Reporting .............................................................................................................. 99 18.1 Reporting Requirements........................................................................................................ 99 18.1.1 Adverse Events (AE) ..................................................................................................... 99 18.1.2 AESIs of Bevacizumab .................................................................................................. 99 18.1.3 Serious Adverse Advents (SAE).................................................................................... 99 18.1.4 Reporting period .......................................................................................................... 100 18.2 Reporting Procedure ........................................................................................................... 100 BEACON-Neuroblastoma Protocol_vn 8.0_vd _07Mar2023 Page 19 of 157 BEACON-Neuroblastoma Trial Protocol 18.2.1 Site............................................................................................................................... 100 18.2.2 Trial Office ................................................................................................................... 102 18.2.3 Reporting to the Competent Authority and main Research Ethics Committee ........... 102 18.2.4 Investigators ................................................................................................................ 102 18.2.5 Data Monitoring Committee ......................................................................................... 102 18.2.6 Manufacturer of Investigational Medicinal Product...................................................... 102 19 Data Handling and Record Keeping ........................................................................................... 103 19.1 Data Collection .................................................................................................................... 103 19.2 Archiving .............................................................................................................................. 103 20 Quality Management .................................................................................................................... 103 20.1 Site Set-up and Initiation ..................................................................................................... 103 20.2 On-site Monitoring ............................................................................................................... 104 20.3 Central Monitoring ............................................................................................................... 104 20.4 Audit and Inspection ............................................................................................................ 104 20.5 Notification of Serious Breaches ......................................................................................... 104 21 End of Trial Definition .................................................................................................................. 105 22 Statistical Considerations ........................................................................................................... 105 22.1 Trial Design.......................................................................................................................... 105 22.2 Definition of Outcome Measures ......................................................................................... 106 22.2.1 Primary ........................................................................................................................ 106 22.2.2 Secondary.................................................................................................................... 106 22.2.3 Exploratory/Tertiary ..................................................................................................... 106 22.3 Sample Size......................................................................................................................... 106 22.4 Interim and Main Analyses of Outcome Measures.............................................................. 108 22.4.1 Planned Interim Analyses ............................................................................................ 108 22.4.2 Main Analysis............................................................................................................... 108 22.5 Stopping Guidelines ............................................................................................................ 110 23 Trial Organisational Structure..................................................................................................... 110 23.1 Coordinating Sponsor .......................................................................................................... 110 23.2 Co-Sponsor Centres ........................................................................................................... 110 23.3 Relationship of trial committees........................................................................................... 112 23.4 Trial Management Group..................................................................................................... 112 23.5 Trial Steering Committee ..................................................................................................... 112 23.6 Data Monitoring Committee................................................................................................. 112 23.7 Finance ................................................................................................................................ 113 23.8 NIHR CRN Portfolio ............................................................................................................. 113 24 Ethical Considerations ................................................................................................................ 113 25 Confidentiality and Data Protection ........................................................................................... 114 26 Insurance and Indemnity ............................................................................................................. 115 27 Publication Policy ........................................................................................................................ 116 28 Reference List............................................................................................................................... 117 Appendix 1 – WMA Declaration of Helsinki .................................................................................... 124 Appendix 2 - Definition of Adverse Events ..................................................................................... 127 Appendix 3 - Common Toxicity Criteria Grading ........................................................................... 129 Appendix 4 – RECIST Criteria 1.1 .................................................................................................... 130 Appendix 5 – Tumor Response at Metastatic Soft Tissue and Bone Sites (Park et al. 2017) ... 133 Appendix 6 - CURIE & SIOPEN scoring methods for neuroblastoma ......................................... 134 Appendix 7 – Temozolomide Dosing............................................................................................... 136 BEACON-Neuroblastoma Protocol_vn 8.0_vd _07Mar2023 Page 20 of 157 BEACON-Neuroblastoma Trial Protocol Appendix 8 – Blood Pressure Levels by Age and Height Percentile for Children and Adolescents ....................................................................................................................................... 139 Appendix 9 – Height for Age Chart - Girls ...................................................................................... 144 Appendix 10 – Height for Age Chart - Boys.................................................................................... 149 Appendix 11 – Lansky and Karnofsky/ECOG Scales .................................................................... 154 Appendix 12 – Tanner Staging ......................................................................................................... 156 Appendix 13 – Clinical studies of anti-GD2 therapies in combination with chemotherapy ...... 157 LIST OF TABLES Table 1 - Second line chemotherapy regimens tested in phase II in relapsed or refractory neuroblastoma since 2000 ..........
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/Media/UHS-website-2019/Docs/PaediatricOncology/beacon-protocol-v8.0-07mar2023-signed.pdf
Ready steady go programme: Easy read booklet - patient information
Description
Easy read information about the Ready steady go programme
Url
/Media/UHS-website-2019/Patientinformation/Childhealth/ReadySteadyGo/Ready-steady-go-programme-Easy-read-booklet-2459-PIL.pdf
Ready Steady Go: Ready questionnaire - patient information
Description
The Ready Steady Go transition programme - Getting Ready The medical and nursing team aim to support you as you get older and help you gradually develop the confidence and skills to take charge of your own healthcare. Filling in this questionnaire will help the team create a programme to suit you. Please answer all questions that are relevant to you and ask if you are unsure. Name: Date: StperRoagerdaamydmyGe o Knowledge and skills KNOWLEDGE I can describe my condition I know when to take my medications, names, doses, how often, etc I know who’s who in the medical and nursing team I understand the differences between children’s and adult health care I know about resources that offer support for young people with my condition SELF ADVOCACY (speaking up for yourself) I feel ready to start preparing to be seen alone for part of the clinic visit in the future I ask my own questions in clinic I have heard and know about ‘Ask 3 Questions’ HEALTH AND LIFESTYLE I understand it is important to exercise for my general health and condition I understand the risks of alcohol, drugs and smoking to my health I understand what appropriate eating means for my general health I am aware that my condition can affect how I develop e.g. puberty I know where and how I can access reliable information about sexual health Yes I would like Comment some extra advice/help with this The Ready Steady Go transition programme - Getting Ready Knowledge and skills Yes I would like Comment some extra advice/help with this DAILY LIVING I can look after myself at home in terms of dressing and bathing/showering etc I can make my own snacks/meals I am able to be away from home overnight SCHOOL AND YOUR FUTURE I am managing at school e.g. getting to and around school, school work, PE, friends, etc I know what I want to do when I leave school LEISURE I can use public transport and access my local community, e.g. shops, leisure centre, cinema I see my friends outside school MANAGING YOUR EMOTIONS I know how to deal with unwelcome comments/ bullying I know someone I can talk to when I feel sad/ fed-up I know how to deal with emotions such as anger or anxiety I am comfortable with the way I look I am happy with life TRANSFER TO ADULT CARE I understand the meaning of ‘transition’ and transfer of information about me Please list anything else you would like help or advice with: Thank you The Ready Steady Go materials were developed by the Transition Steering Group led by Dr Arvind Nagra, paediatric nephrologist and clinical lead for transitional care at Southampton Children’s Hospital, University Hospital Southampton NHS Foundation Trust based on the work of: 1. S Whitehouse and MC Paone. Bridging the gap from youth to adulthood. Contemporary Pediatrics; 1998, December. 13-16. 2. Paone MC, Wigle M, Saewyc E. The ON TRAC model for transitional care of adolescents. Prog Transplant 2006;16:291-302 3. Janet E McDonagh et al, J Child Health Care 2006;10(1):22-42. Users are permitted to use ‘Ready Steady Go’ and ‘Hello to adult services’ materials in their original format purely for non-commercial purposes. No modifications or changes of any kind are allowed without permission of University Hospital Southampton NHS Foundation Trust. The following acknowledgement statement must be included in all publications which make reference to the use of these materials: “Ready Steady Go’ and ‘Hello to adult services’ developed by the Transition Steering Group led by Dr Arvind Nagra, paediatric nephrologist and clinical lead for transitional care at Southampton Children’s Hospital, University Hospital Southampton NHS Foundation Trust based on the work of: 1. S Whitehouse and MC Paone. Bridging the gap from youth to adulthood. Contemporary Pediatrics; 1998, December. 13-16. 2. Paone MC, Wigle M, Saewyc E. The ON TRAC model for transitional care of adolescents. Prog Transplant 2006;16:291-302 3. Janet E McDonagh et al, J Child Health Care 2006;10(1):22-42.” Further information can be found at www.uhs.nhs.uk/readysteadygo April 2020. 2518
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/Media/UHS-website-2019/Patientinformation/Childhealth/ReadySteadyGo/ReadysteadygoReadyquestionnaire.pdf
Ready Steady Go: Parent plan - patient information
Description
Parent/carer’s transition programme Name of parent: Name of patient: Date: Review (1) Review (2) Review (3) Internet access: YES/NO StpeRroagerdaamydmyeGo This transition plan is designed to help parents and carers feel confident about their knowledge and skills during the period of transition. Over the next few years we aim to equip your son/daughter and you with the necessary skills to manage their condition and hopefully increase your confidence and that of your son/daughter to transfer to adult services . Knowledge and skills Yes No N/A I understand the meaning of transition I know who’s in the team and their respective roles I know about resources that offer support for parents/carers of young people with my son/daughter’s condition. I understand what is likely to happen in the future regarding my son/daughter’s condition. I understand the changes (physical and emotional) which occur during adolescence and how their condition potentially affects and is affected by this development. I am confident my son/daughter is knowledgeable about their condition and its therapy. I encourage my child to regularly exercise. I am aware of any restrictions my son/daughter may have. I feel confident in teaching my son/daughter to become responsible for their own medication at home. Parent/carers transition programme Encouraging independence Is your son/daughter independent at home - dressing, bathing, preparing meals, doing chores, etc? I feel confident for my son/daughter to be seen on their own in clinic for part or all of clinic visits I understand my son/daughter’s rights to information, privacy and confidentiality I know how to advise my son/daughter about financial help and other support Yes No N/A Healthy lifestyle I understand the importance of an appropriate healthy diet for young people I understand the effect of smoking, drugs and/or alcohol on my son/daughter’s condition and general health I know where to access reliable sexual health information for young people and their parents Preparation for adult services I feel confident in teaching my son/daughter how to contact the hospital themselves and to organise their repeat prescriptions I understand the differences between paediatric and adult medical care I know the plan for my son/daughter’s medical care when he/she is an adult Please list any other things you have concerns about or would like extra help/advice with: Thank you The Ready Steady Go materials were developed by the Transition Steering Group led by Dr Arvind Nagra, paediatric nephrologist and clinical lead for transitional care at Southampton Children’s Hospital, University Hospital Southampton NHS Foundation Trust based on the work of: 1. S Whitehouse and MC Paone. Bridging the gap from youth to adulthood. Contemporary Pediatrics; 1998, December. 13-16. 2. Paone MC, Wigle M, Saewyc E. The ON TRAC model for transitional care of adolescents. Prog Transplant 2006;16:291-302 3. Janet E McDonagh et al, J Child Health Care 2006;10(1):22-42. Users are permitted to use ‘Ready Steady Go’ and ‘Hello to adult services’ materials in their original format purely for non-commercial purposes. No modifications or changes of any kind are allowed without permission of University Hospital Southampton NHS Foundation Trust. The following acknowledgement statement must be included in all publications which make reference to the use of these materials: “Ready Steady Go’ and ‘Hello to adult services’ developed by the Transition Steering Group led by Dr Arvind Nagra, paediatric nephrologist and clinical lead for transitional care at Southampton Children’s Hospital, University Hospital Southampton NHS Foundation Trust based on the work of: 1. S Whitehouse and MC Paone. Bridging the gap from youth to adulthood. Contemporary Pediatrics; 1998, December. 13-16. 2. Paone MC, Wigle M, Saewyc E. The ON TRAC model for transitional care of adolescents. Prog Transplant 2006;16:291-302 3. Janet E McDonagh et al, J Child Health Care 2006;10(1):22-42.” Further information can be found at www.uhs.nhs.uk/readysteadygo v2.0 2015
Url
/Media/UHS-website-2019/Patientinformation/Childhealth/ReadySteadyGo/Readysteadygoparentplan.pdf
Ready Steady Go: Go questionnaire - patient information
Description
The Ready Steady Go transition programme - Go The medical and nursing team aim to support you as you get older and help you gradually develop the confidence and skills to take charge of your own healthcare. Filling in this questionnaire will help the team create a programme to suit you. Please answer all questions that are relevant to you and ask if you are unsure. Name: Date: StperRoagerdaamydmyGe o Knowledge and skills KNOWLEDGE I am confident in my knowledge about my condition and its management I understand what is likely to happen with my condition when I am an adult I look after my own medication I order and collect my repeat prescriptions and book my own appointments I call the hospital myself if there is a query about my condition and/or therapy SELF ADVOCACY (speaking up for yourself) I feel confident to be seen on my own in clinic I understand my right to confidentiality I understand my role in shared decision making with the healthcare team e.g. Ask 3 questions* HEALTH AND LIFESTYLE I exercise regularly/have an active lifestyle I understand the risks of drugs, alcohol and smoking on my condition and general health I understand what appropriate eating means for my general health I know where and how I can access reliable information about sexual health I understand the implications of my condition and medications on pregnancy/parenting (if applicable) DAILY LIVING I am independent at home – dressing, bathing, showering, preparing meals, etc I can or am learning to drive Yes I would like Comment some extra advice/help with this *See www.uhs.nhs.uk/Media/UHS-website-2019/Patientinformation/Childhealth/ReadySteadyGo/Printready/Ready-Steady-Go-postcard-print-ready.pdf The Ready Steady Go transition programme - Go Knowledge and Skills Yes I would like Comment some extra advice/help with this DAILY LIVING (CONTINUED) I know how to plan ahead for being away from home, overseas, trips e.g. storage of medicines, vaccinations I understand my eligibility for benefits (if applicable) EDUCATION/WORK AND YOUR FUTURE I have had work/volunteering experience I have a Career Plan (please specify) I am aware of the potential impact (if any) of my condition on my future career plans I know how and what to tell a potential employer about my condition (if applicable) I know who to contact for careers advice LEISURE I can use public transport and access my local community, e.g. shops, leisure centre, cinema I see my friends outside school/college/work MANAGING YOUR EMOTIONS I know how to deal with unwelcome comments/ bullying I know someone I can talk to when I feel sad/fed-up I know how to cope with emotions such as anger or anxiety I know where I can get help to deal with my emotions if needed I am comfortable with the way I look I am happy with life TRANSFER TO ADULT CARE I understand the meaning of ‘transition’ and transfer of information about me I know the plan for my care when I am an adult I have all of the information I need about the adult team who will be looking after me Please list anything else you would like help or advice with: Thank you The Ready Steady Go materials were developed by the Transition Steering Group led by Dr Arvind Nagra, paediatric nephrologist and clinical lead for transitional care at Southampton Children’s Hospital, University Hospital Southampton NHS Foundation Trust based on the work of: 1. S Whitehouse and MC Paone. Bridging the gap from youth to adulthood. Contemporary Pediatrics; 1998, December. 13-16. 2. Paone MC, Wigle M, Saewyc E. The ON TRAC model for transitional care of adolescents. Prog Transplant 2006;16:291-302 3. Janet E McDonagh et al, J Child Health Care 2006;10(1):22-42. Users are permitted to use ‘Ready Steady Go’ and ‘Hello to adult services’ materials in their original format purely for non-commercial purposes. No modifications or changes of any kind are allowed without permission of University Hospital Southampton NHS Foundation Trust. The following acknowledgement statement must be included in all publications which make reference to the use of these materials: “Ready Steady Go’ and ‘Hello to adult services’ developed by the Transition Steering Group led by Dr Arvind Nagra, paediatric nephrologist and clinical lead for transitional care at Southampton Children’s Hospital, University Hospital Southampton NHS Foundation Trust based on the work of: 1. S Whitehouse and MC Paone. Bridging the gap from youth to adulthood. Contemporary Pediatrics; 1998, December. 13-16. 2. Paone MC, Wigle M, Saewyc E. The ON TRAC model for transitional care of adolescents. Prog Transplant 2006;16:291-302 3. Janet E McDonagh et al, J Child Health Care 2006;10(1):22-42.” Further information can be found at www.uhs.nhs.uk/readysteadygo April 2020. 2518
Url
/Media/UHS-website-2019/Patientinformation/Childhealth/ReadySteadyGo/ReadysteadygoGoquestionnaire.pdf
Hello to adult services: Steady questionnaire - patient information
Description
The Ready Steady Go transition programme - Steady The medical and nursing team aim to support and help you develop the confidence and skills to take charge of your own healthcare. Filling in this questionnaire will help the team create a programme to suit you. Please answer all questions that are relevant to you and ask if you are unsure. StperRoagerdaamydmyeGo Name: Date: Knowledge and skills Yes I would like Comment some extra advice/help with this Knowledge I understand the medical terms/words and procedures relevant to my condition I understand what each of my medications are for and their side effects I am responsible for my own medication at home I order and collect my repeat prescriptions and book my own appointments I call the hospital myself if there is a query about my condition and/or therapy I know what each member of the medical team can do for me I know who to contact if I have any concerns about my health I know about resources that offer support for young people and adults with my condition SELF ADVOCACY (speaking up for yourself) I feel confident to be seen on my own for some/all of each clinic visit and to ask my own questions I understand my right to confidentiality I understand my role in shared decision making with the healthcare team e.g Ask 3 Questions* HEALTH AND LIFESTYLE I exercise regularly/have an active lifestyle I understand the effect of smoking, drugs and alcohol on my condition and general health I understand what appropriate eating means for my general health I am aware that my condition can affect how I feel and function e.g fatigue, sexual function, fertility I know where and how I can access providers for accurate information about sexual health I understand the implications of my condition and drugs on pregnancy/parenting *See leaflet or www.advancingqualityalliance.nhs.uk/wp-content/uploads/2013/04/BrochureFinal25.10.12.pdf Hteosearlvdliucoelts The Ready Steady Go transition programme - Steady Knowledge and Skills Yes I would like Comment some extra advice/help with this DAILY LIVING I can look after myself in terms of dressing, bathing, making meals etc I know how to plan ahead for being away from home, overseas trips e.g storage of medicine and vaccinations I can or am learning to drive I understand my eligibility for benefits (if applicable) COLLEGE, WORK AND YOUR FUTURE I am managing at college/work e.g getting to and around, nature of work, friends etc I have had experience of working/volunteering I know what I want to do in the future I am aware of the potential impact of my condition on my education/work opportunities I know who to contact for careers advice LEISURE I can use public transport and access my local community, e.g. shops, leisure centre, cinema I have friends and see them socially MANAGING YOUR EMOTIONS I can tell people about my condition e.g. friends, family, employers I know someone I can talk to when I feel sad/fed-up I know how to deal with emotions such as anger or anxiety I am comfortable with the way I look to others I am happy with life Please list anything else you would like help or advice with: Thank you The Ready Steady Go materials were developed by the Transition Steering Group led by Dr Arvind Nagra, paediatric nephrologist and clinical lead for transitional care at Southampton Children’s Hospital, University Hospital Southampton NHS Foundation Trust based on the work of: 1. S Whitehouse and MC Paone. Bridging the gap from youth to adulthood. Contemporary Pediatrics; 1998, December. 13-16. 2. Paone MC, Wigle M, Saewyc E. The ON TRAC model for transitional care of adolescents. Prog Transplant 2006;16:291-302 3. Janet E McDonagh et al, J Child Health Care 2006;10(1):22-42. Users are permitted to use ‘Ready Steady Go’ and ‘Hello to adult services’ materials in their original format purely for non-commercial purposes. No modifications or changes of any kind are allowed without permission of University Hospital Southampton NHS Foundation Trust. The following acknowledgement statement must be included in all publications which make reference to the use of these materials: “Ready Steady Go’ and ‘Hello to adult services’ developed by the Transition Steering Group led by Dr Arvind Nagra, paediatric nephrologist and clinical lead for transitional care at Southampton Children’s Hospital, University Hospital Southampton NHS Foundation Trust based on the work of: 1. S Whitehouse and MC Paone. Bridging the gap from youth to adulthood. Contemporary Pediatrics; 1998, December. 13-16. 2. Paone MC, Wigle M, Saewyc E. The ON TRAC model for transitional care of adolescents. Prog Transplant 2006;16:291-302 3. Janet E McDonagh et al, J Child Health Care 2006;10(1):22-42.” Further information can be found at www.uhs.nhs.uk/readysteadygo v2.0 2015
Url
/Media/UHS-website-2019/Patientinformation/Childhealth/Hello/Hello-to-adult-services-Steady.pdf
Hello to adult services: Ready questionnaire - patient information
Description
The Ready Steady Go transition programme - Getting Ready The medical and nursing team aim to support and help you develop the confidence and skills to take charge of your own healthcare Filling in this questionnaire will help the team create a programme to suit you. Please answer all questions that are relevant to you and ask if you are unsure. StperRoagerdaamydmyeGo Name: Date: Knowledge and skills Yes I would like Comment some extra advice/help with this Knowledge I can describe my condition I know when to take my medications, names, doses, how often, etc I know who’s who in the medical and nursing team I know who to contact if I have any concerns about my health I know about resources that offer support for young people and adults with my condition SELF ADVOCACY (speaking up for yourself) I feel ready to start preparing to be seen alone for part of the clinic visit I ask my own questions in clinic I understand my right to confidentiality I understand my role in shared decision making with the healthcare team e.g. Ask 3 Questions* HEALTH AND LIFESTYLE I exercise regularly/have an active lifestyle I understand what appropriate eating means for my general health I understand the effect of smoking, drugs and alcohol on my condition and general health I am aware that my condition can affect how I feel and function e.g. sexual function, fatigue, fertility I know where and how I can access information about sexual health Hteosearlvdliucoelts *See leaflet or www.advancingqualityalliance.nhs.uk/wp-content/uploads/2013/04/BrochureFinal25.10.12.pdf The Ready Steady Go transition programme - Getting Ready Knowledge and skills Yes I would like Comment some extra advice/help with this DAILY LIVING I can look after myself in terms of dressing, bathing, making meals etc I know how to plan ahead for being away from home, overseas trips e.g storage of medicines, vaccinations I can or am learning to drive COLLEGE, WORK AND YOUR FUTURE I am managing at college/work e.g. getting to and around, nature of work, friends etc... I know what I want to do in the future. I have a career plan LEISURE I can use public transport and access my local community e.g shops, leisure centre, cinema I have friends and see them socially MANAGING YOUR EMOTIONS I feel confident in telling people about my condition e.g. friends, family, employers I know how to deal with emotions such as anger or anxiety I know someone I can talk to when I feel sad/fed-up I am happy with life Please list anything else you would like help or advice with: Thank you The Ready Steady Go materials were developed by the Transition Steering Group led by Dr Arvind Nagra, paediatric nephrologist and clinical lead for transitional care at Southampton Children’s Hospital, University Hospital Southampton NHS Foundation Trust based on the work of: 1. S Whitehouse and MC Paone. Bridging the gap from youth to adulthood. Contemporary Pediatrics; 1998, December. 13-16. 2. Paone MC, Wigle M, Saewyc E. The ON TRAC model for transitional care of adolescents. Prog Transplant 2006;16:291-302 3. Janet E McDonagh et al, J Child Health Care 2006;10(1):22-42. Users are permitted to use ‘Ready Steady Go’ and ‘Hello to adult services’ materials in their original format purely for non-commercial purposes. No modifications or changes of any kind are allowed without permission of University Hospital Southampton NHS Foundation Trust. The following acknowledgement statement must be included in all publications which make reference to the use of these materials: “Ready Steady Go’ and ‘Hello to adult services’ developed by the Transition Steering Group led by Dr Arvind Nagra, paediatric nephrologist and clinical lead for transitional care at Southampton Children’s Hospital, University Hospital Southampton NHS Foundation Trust based on the work of: 1. S Whitehouse and MC Paone. Bridging the gap from youth to adulthood. Contemporary Pediatrics; 1998, December. 13-16. 2. Paone MC, Wigle M, Saewyc E. The ON TRAC model for transitional care of adolescents. Prog Transplant 2006;16:291-302 3. Janet E McDonagh et al, J Child Health Care 2006;10(1):22-42.” Further information can be found at www.uhs.nhs.uk/readysteadygo v2.0 2015
Url
/Media/UHS-website-2019/Patientinformation/Childhealth/Hello/Hello-to-adult-services-Ready.pdf
Hello to adult services: Parent questionnaire - patient information
Description
Parent/carer’s transition programme Name of parent: Name of patient: Date: Review (1) Review (2) Review (3) StperRoagerdaamydmyeGo Internet access: YES/NO This transition programme is designed to help parents and carers feel confident about their knowledge and skills during the period of transition. Over the coming appointments your healthcare team aims to equip your son/daughter and you with the necessary skills to play an appropriate part in the management of their medical condition. Hteosearlvdliucoelts Knowledge and skills Yes No N/A I understand the meaning of transition I know who’s who in the team and their respective roles I know about resources that offer support for parents/carers of young people with my son/daughters condition I understand what is likely to happen in the future regarding my son/daughter’s condition I am aware how their condition can affect how they feel and function e.g. fatigue, sexual function, fertility etc… I am aware how their condition can impact on their future career plans/work (if applicable) I am confident my son/daughter is knowledgeable about their medical condition and its therapy I feel confident in helping my son/daughter to become responsible for their own medication I feel confident helping my son/daughter to contact the hospital themselves if they need to and to organise their own prescriptions. I know the plan for my son/daughters on-going medical care Parent/carers transition programme Encouraging independence Yes No N/A My son/daughter is independent at home e.g. dressing, bathing, preparing meals, chores etc My son/daughter is independent away from the home e.g. getting to and around college/work, using public transport, shopping etc I feel confident for my son/daughter to be seen on their own for part or all of the clinic visit I understand my son/daughters rights to information, privacy and confidentiality I understand my son/daughters role in shared decision making with the healthcare team e.g. Ask 3 Questions I know how to advise my son/daughter about financial matters e.g. eligibility for benefits and other support Healthy lifestyle I understand the importance of an appropriate healthy diet for young people I encourage my son/daughter to regularly exercise. I am aware of any restrictions my son/daughter may have because of their condition I understand the effects of smoking, drugs and alcohol on my son/daughters condition and general health I know where to access reliable sexual health information for young people and their parents Please list any other things you have any concerns about or would like to discuss Thank you The Ready Steady Go materials were developed by the Transition Steering Group led by Dr Arvind Nagra, paediatric nephrologist and clinical lead for transitional care at Southampton Children’s Hospital, University Hospital Southampton NHS Foundation Trust based on the work of: 1. S Whitehouse and MC Paone. Bridging the gap from youth to adulthood. Contemporary Pediatrics; 1998, December. 13-16. 2. Paone MC, Wigle M, Saewyc E. The ON TRAC model for transitional care of adolescents. Prog Transplant 2006;16:291-302 3. Janet E McDonagh et al, J Child Health Care 2006;10(1):22-42. Users are permitted to use ‘Ready Steady Go’ and ‘Hello to adult services’ materials in their original format purely for non-commercial purposes. No modifications or changes of any kind are allowed without permission of University Hospital Southampton NHS Foundation Trust. The following acknowledgement statement must be included in all publications which make reference to the use of these materials: “Ready Steady Go’ and ‘Hello to adult services’ developed by the Transition Steering Group led by Dr Arvind Nagra, paediatric nephrologist and clinical lead for transitional care at Southampton Children’s Hospital, University Hospital Southampton NHS Foundation Trust based on the work of: 1. S Whitehouse and MC Paone. Bridging the gap from youth to adulthood. Contemporary Pediatrics; 1998, December. 13-16. 2. Paone MC, Wigle M, Saewyc E. The ON TRAC model for transitional care of adolescents. Prog Transplant 2006;16:291-302 3. Janet E McDonagh et al, J Child Health Care 2006;10(1):22-42.” Further information can be found at www.uhs.nhs.uk/readysteadygo v2.0 2015
Url
/Media/UHS-website-2019/Patientinformation/Childhealth/Hello/Hello-to-adult-services-Parent-plan.pdf
Hello to adult services: Hello questionnaire - patient information
Description
The Ready Steady Go transition programme - Hello The medical and nursing team aim to support and help you develop the confidence and skills to take charge of your own healthcare. Filling in this questionnaire will help the team create a programme to suit you. Please answer all questions that are relevant to you and ask if you are unsure. Name: Date: StperRoagerdaamydmyeGo Knowledge and skills Yes I would like some extra advice/help with this Knowledge I am confident in my knowledge about my condition and its management. I understand what is likely to happen with my condition in the future I understand what each of my medication/ treatment is for and their side effects I order and collect my repeat prescriptions and book my own appointments I know who to contact if I have any concerns about my health I call the hospital myself if there is a query about my condition or treatment I know about resources for young people or adults with my condition SELF ADVOCACY (speaking up for yourself) I feel confident to be seen on my own in clinic I understand my right to confidentiality I understand my role in shared decision making with the healthcare team e.g. Ask 3 Questions* HEALTH AND LIFESTYLE I exercise regularly/have an active lifestyle I understand the effect of smoking, drugs and alcohol on my condition and general health Comment Hteosearlvdliucoelts I understand what appropriate eating means for my general health I am aware that my condition can affect how I feel and function e.g fatigue, sexual function, fertility I know where and how I can access providers for accurate information about sexual health I understand the implications of my condition and drugs on pregnancy/parenting *See leaflet or www.advancingqualityalliance.nhs.uk/wp-content/uploads/2013/04/BrochureFinal25.10.12.pdf The Ready Steady Go transition programme - Hello Knowledge and Skills Yes I would like Comment some extra advice/help with this DAILY LIVING I am independent at home – dressing, bathing, preparing meals etc I know how to plan ahead for being away from home, overseas trips e.g. storage of medicine and vaccinations I can or am learning to drive I understand my eligibility for benefits (if applicable) COLLEGE, WORK AND YOUR FUTURE I am managing at college/work e.g getting to and around, nature of work, friends etc I have had experience of working/volunteering I have a career plan - please specify I am aware of the potential impact (if any) of my condition on my future plans I know how and what to tell a potential employer about my condition (if applicable) I know who to contact for careers advice LEISURE I can use public transport and access my local community e.g shops, leisure centre,cinema I have friends and see them socially MANAGING YOUR EMOTIONS I feel confident in telling people about my condition e.g. friends, family, employers I know someone I can talk to if I feel sad/fed-up I know how to cope with emotions such as anger or anxiety I would like more information about where I can get help to deal with my emotions I am comfortable with the way I look to others I am happy with life Please list anything else you would like help or advice with: Thank you The Ready Steady Go materials were developed by the Transition Steering Group led by Dr Arvind Nagra, paediatric nephrologist and clinical lead for transitional care at Southampton Children’s Hospital, University Hospital Southampton NHS Foundation Trust based on the work of: 1. S Whitehouse and MC Paone. Bridging the gap from youth to adulthood. Contemporary Pediatrics; 1998, December. 13-16. 2. Paone MC, Wigle M, Saewyc E. The ON TRAC model for transitional care of adolescents. Prog Transplant 2006;16:291-302 3. Janet E McDonagh et al, J Child Health Care 2006;10(1):22-42. Users are permitted to use ‘Ready Steady Go’ and ‘Hello to adult services’ materials in their original format purely for non-commercial purposes. No modifications or changes of any kind are allowed without permission of University Hospital Southampton NHS Foundation Trust. The following acknowledgement statement must be included in all publications which make reference to the use of these materials: “Ready Steady Go’ and ‘Hello to adult services’ developed by the Transition Steering Group led by Dr Arvind Nagra, paediatric nephrologist and clinical lead for transitional care at Southampton Children’s Hospital, University Hospital Southampton NHS Foundation Trust based on the work of: 1. S Whitehouse and MC Paone. Bridging the gap from youth to adulthood. Contemporary Pediatrics; 1998, December. 13-16. 2. Paone MC, Wigle M, Saewyc E. The ON TRAC model for transitional care of adolescents. Prog Transplant 2006;16:291-302 3. Janet E McDonagh et al, J Child Health Care 2006;10(1):22-42.” Further information can be found at www.uhs.nhs.uk/readysteadygo v2.0 2015
Url
/Media/UHS-website-2019/Patientinformation/Childhealth/Hello/Hello-to-adult-services-Hello.pdf
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Last updated: 14 September 2019
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